Ophthalmic surgical systems, methods, and devices

ABSTRACT

The disclosure herein provides ophthalmic surgical systems, methods, and devices. In one embodiment, a surgical apparatus for use by a surgeon during a surgical procedure comprises one or more sealed sterilized surgical packs configured to be disposed of after a single or a limited number of surgical procedures, the one or more sealed sterilized surgical packs comprising: a sterile surgical instrument; and a sterile surgical tray comprising a top surface configured to be part of a sterile field of the surgical procedure, the top surface comprising a receiving structure for positioning therein of the sterile surgical instrument, the sterile surgical tray further comprising walls that define a recess sized and configured to receive a reusable non-sterile module, the recess configured to encapsulate the reusable non-sterile module to isolate the reusable non-sterile module from the sterile field of the surgical procedure.

This application is a continuation application of U.S. patentapplication Ser. No. 15/970,349 titled OPHTHALMIC SURGICAL SYSTEMS,METHODS, AND DEVICES filed on May 3, 2018 which was a continuationapplication of U.S. patent application Ser. No. 14/608,915 titledOPHTHALMIC SURGICAL SYSTEMS, METHODS, AND DEVICES filed on Jan. 29, 2015which was a continuation-in-part of U.S. patent application Ser. No.14/554,865, titled OPHTHALMIC SURGICAL SYSTEMS, METHODS, AND DEVICES,filed Nov. 26, 2014. This application also claims the benefit ofpriority (through one or more of the previous listed applications) ofU.S. Provisional Application No. 62/091,384, titled MULTI-USE SURGICALTRAY SYSTEM, filed Dec. 12, 2014, U.S. Provisional Application No.61/990,021, titled OPHTHALMIC SURGICAL SYSTEMS, filed May 7, 2014, U.S.Provisional Application No. 61/924,164, titled OPHTHALMIC SURGICALSYSTEMS, filed Jan. 6, 2014, and of U.S. Provisional Application No.61/910,112, titled OPHTHALMIC SURGICAL SYSTEMS, filed Nov. 28, 2013.Each of the foregoing applications (Ser. Nos. 15/970,349; 14/608,915;14/554,865; 62/091,384; 61/990,021; 61/924,164; and 61/910,112) arehereby incorporated by reference in their entirety as though fully andcompletely set forth herein.

BACKGROUND Field

The disclosure relates generally to the field of ophthalmic surgery, andmore specifically to ophthalmic surgical systems, methods, and devices.

Description

The field of ophthalmology has become increasingly important in today'ssociety as adults are living longer and older generations comprise agrowing proportion of the world population. Vision care and thetreatment of ocular diseases or conditions have benefited in recentyears from advancements in both pharmacology and medical devicetechnologies. Microsurgical instruments and innovative surgicaltechniques enable surgeons to repair or replace parts of the eyepreviously considered inaccessible and off-limits. In particular,console systems that provide a variety of functions dedicated to aspecific set of procedures (such as vitrectomy or cataract removalprocedures) are now available to surgeons, with improvements and updatesto the technology occurring on a regular basis. Often times theseconsoles are very expensive, requiring a large capital expenditure by asurgeon, hospital, or ambulatory surgical center. They also often havehigh recurring costs for the single-use disposable elements of thesystem, and may have high maintenance costs as well. The consoles oftenincorporate a lot of unnecessary or infrequently used functionality inorder to differentiate from competing products. Hence, in addition tobeing costly, the consoles are often large, heavy, bulky, noisy,power-hungry, and bloated machines that contrast sharply with the small,delicate eye they are designed to treat. Furthermore, the drawbacks ofthese systems often require them to be located some distance from thesurgeon, resulting in long tubing sets and/or cables that negativelyimpact the performance of the system while increasing the cost. Hence,there is a need for smaller, more portable, more self-contained, andmore cost-effective systems that incorporate the major functionsrequired to perform certain procedures.

SUMMARY

The disclosure herein provides ophthalmic surgical systems, methods, anddevices. In some embodiments, a surgical apparatus or tray comprises oneor more reusable components and one or more disposable componentsconfigured to be used with the reusable components. In some embodiments,the disposable components can be configured to be disposed of after asingle use or a limited number of uses. In some embodiments, the one ormore reusable portions comprise a non-sterile component configured tonot be in a sterile surgical environment, while the one or moredisposable components are configured to be used in the sterile surgicalenvironment. In some embodiments, a sterile disposable portion isconfigured to encapsulate or otherwise isolate a non-sterile reusableportion from a sterile surgical environment. In some embodiments, ahandheld surgical instrument comprises a pressure sensitive button forcontrolling a surgical function. In some embodiments, the pressuresensitive button is positioned circumferentially around a body of thesurgical tool, such that external pressure applied to the button at anyor substantially any location around the circumference (or at anylocation within a predefined range, such as, for example, about 350,325, 300, 275, 250, 225, 200, or 180 degrees of the full circumference)is detectable by the pressure sensitive button. In some embodiments, ahandheld surgical instrument comprises a nonelectric button, such as,for example, a pneumatic, hydraulic, optical, and/or the like button. Insome embodiments, an ophthalmic surgical system is configured to utilizea reusable base and a disposable sterile surgical tray coupled thereto.In some embodiments, some functions are contained within or coupled tothe disposable tray, such as, for example, fluidics and/or handpieces;and reusable components, such as, for example, a power source (forexample, electrical, mechanical, hydraulic, pneumatic, optical, and/orthe like) for the handpieces located in the reusable base. In someembodiments, a custom surgical drape is provided which comprises one ormore functional interfaces enabling a function to pass therethrough. Insome embodiments, the function configured to pass therethrough maycomprise an electrical current, light, pneumatic or fluidic coupling,and/or a mechanical coupling or other feature. In some embodiments, anophthalmic surgical system is configured to be automatically updated orconfigured in response to detection of a tag, such as an RFID tag, anear field communication device, a memory card/USB, or other storagedevice, and/or the like.

According to some embodiments, a surgical apparatus for use by a surgeonduring a surgical procedure comprises: one or more sealed sterilizedsurgical packs configured to be unsealed before a surgical procedure anddisposed of after a single or a limited number of surgical procedures,the one or more sealed sterilized surgical packs comprising: a sterilesurgical instrument; and a sterile surgical tray comprising a topsurface configured to be part of a sterile field of the surgicalprocedure, the sterile surgical tray further comprising walls thatdefine a recess sized and configured to receive a reusable non-sterilemodule, the recess configured to fully or partially encapsulate thereusable non-sterile module to isolate the reusable non-sterile modulefrom the sterile field of the surgical procedure, wherein the walls ofthe sterile surgical tray comprises one or more interfaces positionedand configured to enable one or more functions of the reusablenon-sterile module to be utilized in the sterile field of the surgicalprocedure outside of the recess. In some embodiments, the one or moreinterfaces comprises at least an electronic communication interfaceconfigured to enable an electronic controller of the reusablenon-sterile module to electronically communicate with the sterilesurgical tray or the sterile surgical instrument.

In some embodiments, the recess is centrally located in the sterilesurgical tray. In some embodiments, the sterile surgical tray comprisesat least two pieces selectively coupleable together to form the recessthat encapsulates the reusable non-sterile module. In some embodiments,the sterile surgical tray comprises a hinged opening for access to therecess. In some embodiments, the one or more interfaces comprises amechanical coupling for transmission of rotational motion from a motorof the reusable non-sterile module to a fluid pump connected to thesterile surgical tray. In some embodiments, the one or more interfacescomprises a light transmission coupling for transmission of light from alight source of the reusable non-sterile module to the sterile surgicalinstrument. In some embodiments, the one or more interfaces comprises anelectrically conductive coupling for transmission of electrical powerfrom the non-sterile module to the sterile surgical tray. In someembodiments, the one or more interfaces comprises an electroniccommunication coupling for enabling electronic communication between thenon-sterile module and the sterile surgical tray or sterile surgicalinstrument. In some embodiments, the one or more functions of thereusable non-sterile module comprise at least one of the following:providing mechanical power, providing electrical power, providingelectronic processing or control, providing a laser source, providing alight source, and displaying information. In some embodiments, the topsurface of the sterile surgical tray comprises a receiving structure forpositioning therein of the sterile surgical instrument.

According to some embodiments, a surgical apparatus for use by a surgeonduring a surgical procedure comprises: one or more sealed sterilizedsurgical packs configured to be unsealed before a surgical procedure anddisposed of after a single or a limited number of surgical procedures,the one or more sealed sterilized surgical packs comprising: a sterilesurgical instrument; and a sterile surgical tray comprising a topsurface configured to be part of a sterile field of the surgicalprocedure, and a bottom surface sized and configured to couple to and besupported by an upper surface of a reusable support structure, thereusable support structure comprising at least one of: a motor, a lightsource, and a user interface display, wherein the sterile surgical traycomprises at least one of: a mechanical coupling for transmission ofrotational motion from the motor of the support structure to a fluidpump connected to the sterile surgical tray, a light transmissioncoupling for transmission of light from the light source of the supportstructure to the sterile surgical instrument, and a transparent materialpositioned to enable the user interface display of the support structureto be visible therethrough in the sterile field of the surgicalprocedure.

In some embodiments, the one or more sealed sterilized surgical packsfurther comprises a sterile drape sized to be positioned between thebottom surface of the sterile surgical tray and the upper surface of thereusable support structure. In some embodiments, the sterile drapecomprises a conductive interface configured to enable electrical currentto pass from the reusable support structure to the sterile surgicaltray. In some embodiments, the reusable support structure isnon-sterile. In some embodiments, the sterile surgical tray comprises acollapsed shipping configuration and an expanded surgical useconfiguration. In some embodiments, at least a portion of the sterilesurgical tray is configured to, in the collapsed shipping configuration,protect the sterile surgical tool from damage. In some embodiments, thereusable support structure comprises the motor, and the one or moresealed sterilized surgical packs further comprises a sterile pump moduleseparate from the sterile surgical tray and configured to separatelycouple to and be supported by the reusable support structure, whereinthe sterile pump module comprises a rotational coupling for transmissionof rotational motion from the motor to a fluid pump of the pump module.In some embodiments, the top surface of the sterile surgical traycomprises a receiving structure for positioning therein of the sterilesurgical instrument.

According to some embodiments, a surgical apparatus for use by a surgeonduring a surgical procedure comprises: one or more sealed sterilizedsurgical packs configured to be unsealed before a surgical procedure anddisposed of after a single or a limited number of surgical procedures,the one or more sealed sterilized surgical packs comprising: a sterilesurgical instrument; a sterile surgical instrument holder comprising atop surface configured to be part of a sterile field of the surgicalprocedure, the top surface comprising a receiving structure forpositioning therein of the sterile surgical instrument, the sterilesurgical instrument holder further comprising a bottom surface sized andconfigured to be received in a first recess of a reusable supportstructure; and a sterile infusion module sized and configured to bereceived in a second recess of the reusable support structure, thesterile infusion module comprising a pump head configured to couple witha motor of the reusable support structure to enable pumping of fluidsinto the sterile field or surgical site. In some embodiments, the one ormore sealed sterilized surgical packs further comprises (or the sterilesurgical instrument, sterile surgical instrument holder, and/or sterileinfusion modules is replaced with) a sterile aspiration modulecomprising a pump head configured to couple with the motor of thereusable support structure to enable pumping of fluids out of thesterile field or surgical site. In some embodiments, the sterileinfusion module and/or sterile aspiration module comprises a pump headcoupled to a motor, instead of a pump head configured to couple with amotor of the reusable support structure.

In some embodiments, the sterile surgical instrument holder comprises acollapsed configuration and an expanded configuration, the collapsedconfiguration configured to protect the surgical instrument in shipping,the expanded configuration configured to enable access to the surgicalinstrument in the sterile field of the surgical procedure. In someembodiments, the one or more sealed sterilized surgical packs furthercomprises a second sterile surgical instrument holder comprising areceiving structure for positioning therein of a second sterile surgicalinstrument, the surgical instrument holders shaped and configured tocouple together in a collapsed configuration for protection of thesurgical instruments in shipping. In some embodiments, the surgicalinstrument is configured to couple with one or more of: a light sourceof the reusable support structure, an electronic controller of thereusable support structure, a mechanical driver of the reusable supportstructure (for example, a transmission cable or torque coil, and/or thelike), and a pneumatic or fluidic driver of the reusable supportstructure (for example, a pump, compressed source, and/or the like). Insome embodiments, the reusable support structure is non-sterile. In someembodiments, the one or more scaled sterilized surgical packs furthercomprises a surgical drape configured be positioned between thenon-sterile reusable support structure and at least one of the surgicalinstrument holder and the infusion module.

According to some embodiments, a surgical apparatus for use by a surgeonduring a surgical procedure comprises: one or more sealed sterilizedsurgical packs configured to be unsealed before a surgical procedure anddisposed of after a single or a limited number of surgical procedures,the one or more sealed sterilized surgical packs comprising one or moreof a sterile infusion module and a sterile aspiration module, thesterile infusion and aspiration modules each comprising: a housingcomprising walls sized and configured to be removably received in arecess of a reusable support structure, and at least one outer surfaceconfigured to be part of the sterile field of the surgical procedure; apump for pumping fluids into or out of a surgical site; and a motorcoupled to the pump for rotating a rotor of the pump, wherein thehousing further comprises an electrical interface configured to receiveelectrical power from the reusable support structure for powering themotor, wherein the sterile infusion module is configured to pump fluidsinto the surgical site, and the sterile aspiration module is configuredto pump fluids out of the surgical site.

In some embodiments, the one or more sealed sterilized surgical packscomprises at least one of each of the sterile infusion module and thesterile aspiration module. In some embodiments, the pump comprises asterilization configuration wherein at most one pinch-point is createdin peristaltic tubing of the pump. In some embodiments, the pumpcomprises a plurality of rollers repositionable from a sterilizationposition to an operating position, wherein, in the sterilizationposition, the rollers are closer to a central axis of the pump than inthe operating position. In some embodiments, the one or more sealedsterilized surgical packs further comprises: a sterile surgicalinstrument; and a sterile surgical instrument holder comprising a topsurface configured to be part of the sterile field of the surgicalprocedure, the top surface comprising a receiving portion forpositioning therein or thereon of the sterile surgical instrument, thesterile surgical instrument holder further comprising a bottom surfacesized and configured to be received in a different recess of thereusable support structure. In some embodiments, the reusable supportstructure is non-sterile, and the one or more sealed sterilized surgicalpacks further comprises a surgical drape configured be positionedbetween the non-sterile reusable support structure and at least one ofthe modules.

According to some embodiments, a handheld medical instrument forsurgical procedures comprises: a body having an exterior surface shapedto be held and manipulated by a human hand; a surgical tool extendingfrom a distal end of the body; and a pressure-sensitive button forcontrolling operation of the surgical tool, the pressure-sensitivebutton comprising an actuation surface positioned adjacent the exteriorsurface of the body, the pressure-sensitive button further comprising apressure detection device, the pressure detection device configured toenable output of a signal for controlling a function of the surgicaltool, the signal being proportional to a position of the actuationsurface.

In some embodiments, the pressure detection device comprises a forcesensitive resistor that changes a resistance based on the position ofthe actuation surface. In some embodiments, the actuation surfaceextends circumferentially around an exterior of the body and ispositioned at least partially around a conductive surface of the forcesensitive resistor. In some embodiments, the pressure detection devicecomprises an optical fiber positioned such that movement of theactuation surface with respect to the body causes the optical fiber todeform. In some embodiments, the pressure detection device comprises anoptical fiber and an optical detection member, wherein movement of theactuation surface with respect to the body causes the optical detectionmember to move in a way that affects a light signal of the opticalfiber. In some embodiments, the pressure detection device comprises adeformable member coupled to the actuation surface such that movement ofthe actuation surface with respect to the body deforms the deformablemember, causing a change in pressure within the deformable member. Insome embodiments, the pressure detection device comprises apiezoelectric material coupled to the actuation surface such thatmovement of the actuation surface with respect to the body causesdeformation of the piezoelectric material. In some embodiments, thesurgical tool comprises at least one of: an aspiration device, anendoillumination device, a laser therapy device, a lens removal device,a trabecular meshwork removal device, and a vitreous cutting device. Insome embodiments, the controlled function of the surgical tool comprisesat least one of: a speed and an intensity. For example, the controlledfunction can be configured to be controlling the intensity of infusionpressure or aspiration vacuum. In some embodiments, the proportionalityof the signal in relation to the position of the actuation surface islinear. The term “linear” as used herein is a broad term, and unlessotherwise indicated, the term can include within its meanings, withoutlimitation, a reference to the concept of a variable output that isproportional to some input (for example, the applied force ordeflection), but in some embodiments, the term “linear” can refer to aresponse that is not necessarily a linearly proportional response andcan include a non-linear response (for example, logarithmic orexponential response based on a linear input), and in some embodiments,the term “linear” can refer to a response that is a combination of alinear and non-linear response (for example, the initial range of aninput produces an initial response that is linear and a second range ofthe input produces a response that is non-linear). In some embodiments,the actuation surface is movable between a fully outward position and afully depressed position, wherein the actuation surface is biasedoutward, such that the actuation surface remains in the fully outwardposition until an external force is applied that overcomes a biasingforce. In some embodiments, the signal is configured to controlsimultaneously the function of the surgical tool and at least one othersurgical function. In some embodiments, the handheld medical instrumentfurther comprises a second pressure-sensitive button comprising a secondactuation surface and second pressure detection device configured toenable controlling of a second surgical function. In some embodiments,the handheld medical instrument further comprises a tether coupled to asurgical tray. In some embodiments, the pressure detection device isconfigured to transmit the signal to a processor (for example, acomputer process, controller, microelectronics, and/or the like)external to the medical instrument for interpretation of the signal forcontrolling of the function of the surgical tool. In some embodiments,the signal controls the function of the surgical tool without the signalbeing transmitted to a processor external to the medical instrument forinterpretation. In some embodiments, the body comprises at least one ofthe following: an elongate cylindrical shape and an elongate roundedshape.

According to some embodiments, a handheld medical instrument forsurgical procedures comprises: a body having an exterior surface shapedto be held and manipulated by a human hand; a surgical tool extendingfrom a distal end of the body; a button for controlling operation of thesurgical tool, the button positioned adjacent the exterior surface ofthe body, wherein the button comprises a non-electrical detectionmechanism; and a signal transfer conduit configured to enable output ofa signal from the non-electrical detection mechanism for controlling afunction of the surgical tool.

In some embodiments, the signal transfer conduit comprises an opticalfiber, and the detection mechanism comprises an end surface of theoptical fiber. In some embodiments, the signal transfer conduitcomprises an optical fiber, and the detection mechanism comprises anoptical detection member, wherein movement of the optical detectionmember with respect to the body affects a light signal of the opticalfiber. In some embodiments, the signal transfer conduit comprises anoptical fiber, and the detection mechanism comprises a portion of theoptical fiber that is deformable by movement of an actuation surfacewith respect to the body. In some embodiments, the signal transferconduit comprises one of a pneumatic and a hydraulic tube, and thedetection mechanism comprises an opening of the tube or an openingfluidly coupled to the tube, the opening positioned adjacent theexterior surface of the body. In some embodiments, the signal transferconduit comprises one of a pneumatic and a hydraulic tube, and thedetection mechanism comprises an actuation surface movably coupled tothe body, wherein movement of the actuation surface with respect to thebody causes to deform one of a portion of the tube and a deformablemember fluidly coupled to the tube. In some embodiments, the surgicaltool comprises at least one of: an aspiration device, anendoillumination device, a laser therapy device, a lens removal device,a trabecular meshwork removal device, and a vitreous cutting device. Insome embodiments, the controlled function of the surgical tool comprisesat least one of: a speed and an intensity. In some embodiments, thehandheld medical instrument further comprises a tether coupled to asurgical tray. In some embodiments, the pressure detection device isconfigured to transmit the signal to a processor external to the medicalinstrument for interpretation of the signal for controlling of thefunction of the surgical tool. In some embodiments, the body comprisesat least one of the following: an elongate cylindrical shape and anelongate rounded shape.

According to some embodiments, a surgical drape for use in a sterileoperating field comprises: a flexible sheet sized to be at leastpartially sandwiched between first and second surgical devices and to atleast partially cover the second surgical device to maintain a sterilebarrier between the first and second surgical devices; and at least oneaccess interface integrally formed or coupled to the flexible sheet,wherein the access interface is configured to enable at least one of thefollowing to pass therethrough while maintaining the sterile barrier:electrical current, light, a mechanical coupling, an optical coupling, afluid coupling, and a pneumatic coupling.

In some embodiments, the access interface is positionable at anelectrical interface of the first and second surgical devices, and theaccess interface comprises electrical contacts configured to enableelectrical current to pass therethrough. In some embodiments, the accessinterface is positionable at an electrical interface of the first andsecond surgical devices, and the access interface comprises ananisotropically conductive material. In some embodiments, the accessinterface comprises an optically-transparent window. In someembodiments, the access interface comprises a perforated region. In someembodiments, the functional interface comprises a scaling feature thatforms a seal around the perforated region. In some embodiments, theaccess interface comprises a region to be punctured. In someembodiments, the functional interface comprises a sealing feature thatforms a seal around the punctured region. In some embodiments, thesecond surgical device comprises a reusable base, and the first surgicaldevice comprises a sterile surgical tray configured to be releasablycoupled to the base, wherein the flexible sheet is form-fitted to thereusable base.

For purposes of this summary, certain aspects, advantages, and novelfeatures of the invention are described herein. It is to be understoodthat not necessarily all such advantages may be achieved in accordancewith any particular embodiment of the invention. Thus, for example,those skilled in the art will recognize that the invention may beembodied or carried out in a manner that achieves one advantage or groupof advantages as taught herein without necessarily achieving otheradvantages as may be taught or suggested herein.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features, aspects, and advantages of the presentinvention are described in detail below with reference to the drawingsof various embodiments, which are intended to illustrate and not tolimit the invention. The drawings comprise the following figures inwhich:

FIGS. 1A-1F illustrate an embodiment of a surgical tray that may be usedfor an ophthalmic surgical procedure.

FIGS. 2A-2K illustrate a variety of embodiments of coupling mechanisms.

FIGS. 3A-3C illustrates embodiments of functional surgical drapes.

FIGS. 4A-4F illustrate embodiments of a modular surgical tray system.

FIGS. 5A and 5B illustrate another embodiment of a modular surgical traysystem.

FIGS. 6A-6F illustrate another embodiment of a modular surgical traysystem.

FIG. 7 illustrates another embodiment of a surgical tray system.

FIGS. 8A and 8B illustrate an embodiment of a handpiece having aplurality of buttons.

FIGS. 9A-9D illustrate example embodiments of handpieces comprising oneor more optical buttons.

FIGS. 10A-10C illustrate example embodiments of handpieces comprisingpneumatic or hydraulic buttons.

FIG. 11 illustrates an embodiment of a handpiece comprising apiezoelectric button.

FIGS. 12A-12C illustrate an embodiment of a surgical tray system thatisolates a non-sterile reusable component from a sterile surgical field.

FIGS. 13A-13C illustrate another embodiment of a surgical tray systemthat isolates a non-sterile reusable component from a sterile surgicalfield.

FIGS. 14A-14C illustrate another embodiment of a surgical tray systemthat isolates a non-sterile reusable component from a sterile surgicalfield.

FIG. 15 illustrates another embodiment of a modular surgical traysystem.

FIGS. 16A and 16B illustrates another embodiment of a modular surgicaltray system.

FIGS. 17A-17C illustrate an embodiment of a bottle holder that isolatesa non-sterile BSS bottle from a sterile surgical field.

FIG. 18 illustrates an embodiment of a peristaltic pump head configuredto accommodate gas sterilization.

FIGS. 19A and 19B illustrate another embodiment of a peristaltic pumphead configured to accommodate gas sterilization.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Although several embodiments, examples, and illustrations are disclosedbelow, it will be understood by those of ordinary skill in the art thatthe invention described herein extends beyond the specifically disclosedembodiments, examples, and illustrations and includes other uses of theinvention and obvious modifications and equivalents thereof. Embodimentsof the invention are described with reference to the accompanyingfigures, wherein like numerals refer to like elements throughout. Theterminology used in the description presented herein is not intended tobe interpreted in any limited or restrictive manner simply because it isbeing used in conjunction with a detailed description of certainspecific embodiments of the invention. In addition, embodiments of theinvention can comprise several novel features and no single feature issolely responsible for its desirable attributes or is essential topracticing the inventions herein described.

Some embodiments comprise a surgical tray or console that is locatedadjacent to the surgical site or nearby (e.g. adjacent to or around thepatient's head during eye surgery). The tray may be U-shaped, L-shaped,or otherwise curved or angled to accommodate the anatomy of the surgicalsite. Some embodiments comprise a surgical tray that is mounted,secured, or otherwise attached to the patient gurney, patient headrest,surgeon's armrest, or surgical microscope through a temporary,semi-permanent, or permanent means. Some embodiments comprise a separatepermanent or semi-permanent base unit that is securely mounted to thegurney, armrest, or other fixture such that the tray can be securelyseated or positioned on the base. In some embodiments, the base replacesthe surgeon's armrest or is mounted to the armrest and is thereforedesigned with the strength to support the surgeon's arms and hands. Inother embodiments, the tray itself mounts directly to the fixture(armrest, gurney, microscope, etc.), for example using clips, straps,clamps, or other features to enable a secure mounting.

Modular or Hybrid Surgical Tray

In some embodiments, a modular or hybrid surgical apparatus or traycomprises one or more reusable components and one or more disposablecomponents (which in some embodiments can be disposed of after a singleuse or in some embodiments can be disposed of after a limited number ofuses) with at least portions of each contained within or in closeproximity to the sterile work area. For example, one or more disposablecomponents may comprise sterile components configured to be presentwithin the sterile work area, and one or more reusable components may beconfigured to be at least partially contained within a disposablesterile component, encapsulated within a disposable sterile component,or otherwise isolated from the sterile work area (for example, using asterile drape) while remaining in close proximity to the sterile workarea.

In a typical use scenario, the one or more reusable components are notnecessarily considered sterile, while the one or more disposableportions are provided in sterile packaging for use during a surgicalprocedure. A non-sterile reusable portion provides one or more functionsin conjunction with the sterile portion of the system, but for one ormore reasons, the reusable portion is not designed to be single use ordisposable. For example, the reusable portion may include componentsthat are or may be perceived to be too expensive, too large, toovaluable, too wasteful, or too hazardous to dispose of after a singleuse. There are several benefits with a hybrid surgical tray system thatintegrates both disposable and reusable aspects, including but notlimited to costs savings, reduced environmental impact, and higher salesmargins.

The disposable portion(s) may in some embodiments comprise components ofthe system that are contaminated during use, wear out after a singleuse, or are otherwise not appropriate for extended use or multiple uses.These components may include (but are not limited to) fluidic tubinglines, fluidic components including fluidic connectors, stopcocks, checkvalves, filters, pumps or portions thereof (for example, pump tubing,peristaltic pump rotor and rollers, and/or the like), pressure and flowsensors, and/or the like; instruments that are inserted into the eye orother surgical site (or portions of the instruments, such as a removableneedle); sterile drapes, bags, shells, or other coverings; trays,enclosures, work surfaces, instrument holders, and/or other structuralelements of the surgical tray. In some embodiments, the disposables mayalso include electronics, electrical interconnects, and/or batteries. Insome embodiments the disposables may include optical components,including but not limited to fibers, fiber bundles, light pipes, LEDs,lenses, and/or the like.

Reusable portion(s) may in some embodiments comprise components that arenot contaminated during a surgical procedure (in some embodiments by thedesign of the hybrid/modular surgical apparatus) or can be sterilized orotherwise decontaminated after use. These components may comprise (butare not limited to) electronics, displays, power supplies, batteries,pumps or portions thereof (for example, motor and/or gear assembly),lasers, light sources, optical components, compressors, gas sources,enclosures, work surfaces, instrument holders, other structural elementsof the surgical tray, and/or the like.

A significant challenge associated with a “multi-use” surgical traysystem as described in this disclosure (such as, for example, a hybridor modular system comprising both disposable and reusable components) isensuring the design and the usage of the system adheres to propersterile procedures and risk of contamination considerations. Inparticular, the interfacing requirements between the sterile disposableportion(s) of the tray and the non-sterile reusable portion(s) poses achallenge. In many current state of the art surgical systems, a reusablesurgical assembly would be located some distance away from the sterilefield and surgical site, with an extended length interface (for example,electrical cable, optical fiber, pneumatic/fluidic tubing, and/or thelike) crossing the sterile and non-sterile barrier to connect thereusable assembly to a disposable assembly (for example, a surgicalhandheld instrument). Embodiments of the present disclosure, however,include both a non-sterile reusable portion and a sterile disposableportion within or in close proximity to the sterile work area.

One technique to accomplish this functional interfacing is a drape orcover that allows for interfacing of one or more types (for example,electrical, mechanical, optical, fluidic, and/or the like) through thedrape or cover such that a sterile barrier between the steriledisposable portion and non-sterile reusable portion is maintained. Anexample of this functional drape technique is described in more detailbelow with reference to FIGS. 3A-3C.

Other techniques to accomplish this functional interfacing of thesterile and non-sterile components (or disposable and reusablecomponents) within or in close proximity to the sterile work area, whileadhering to standard sterile practices in a surgical operating roomsetting, are also disclosed herein. In some embodiments, a steriledisposable portion of the system (either alone or in combination withone or more other disposable or reusable portions) serves as a sterileaseptic container that encloses, covers, or otherwise protects orisolates the non-sterile reusable portion (or multiple non-sterileportions) such that a sterile barrier is always maintained during asurgical procedure. This can be preferable to the drape solution inthat, in some embodiments, there is no need for a more costly or customdesigned drape, and, in some embodiments, there is no need to penetrate,puncture, or otherwise pass something through the sterile drape, since,in some embodiments, the sterile disposable portion surrounds or encasesthe non-sterile reusable portion, and any required functional interfacesbetween the two or more portions can be made directly. In someembodiments, however, it can be desirable to combine both concepts,namely, utilizing both a drape having functional interfaces and asterile component that at least partially isolates a non-sterilecomponent.

In an example use scenario of a sterile component that isolates anon-sterile component from the sterile work area, an aseptic transferprocedure is used to unpackage and set up a multi-use surgical tray. Asurgeon who has “scrubbed in” and is properly gowned (and thereforeuncontaminated) would be present within the sterile work area, and anassistant (who is not considered to be sterile) would be present outsidethe sterile work area. The assistant would open and present a sterilepackaged tray (disposable portion) to the surgeon, the assistant onlytouching the outer packaging (which is not considered sterile) and notthe sterile tray itself. The surgeon would remove the disposable trayfrom the packaging without touching the outside of the packaging. In asingle use tray embodiment (whereby the entire tray is disposed of aftera surgical procedure, thus requiring no interfacing between a disposableand reusable portion) the tray would now be set up near the patient andthe surgery would commence. In a multi-use or hybrid embodiment, thesurgeon would then open or otherwise enable access to an asepticenclosure that is part of the sterile tray into which the assistantwould place the non-sterile reusable module. Various embodimentsdisclosed herein, for example FIGS. 12A-12C, 13A-13C, and 14A-14C,described in further detail below, illustrate such a multi-use or hybridsurgical tray that comprises an aseptic enclosure or cavity forinsertion therein of a non-sterile reusable module.

In some embodiments, to reduce the size of a disposable portion of asurgical tray (which can, for example, help reduce overall cost andwaste), the disposable portion may be designed to be large enough tocontain (for example, to fully or partially encapsulate) the reusablemodule (containing functional elements), but other structural orsupporting aspects of the tray that do not require functionalinterfacing to the reusable module can be designed to also be reusableand, for example, draped prior to a surgical procedure. The disposableportion may also in some embodiments comprise a relatively thin plasticor similar material (for example, injection molding or vacuum formingbeing preferred options for low cost and thin plastic features), withadditional structural support being provided by the reusable portionupon which it rests or otherwise couples to. The disposable portion mayin some embodiments function as a drape or sterile barrier (reducing oreliminating the need for a normal drape), or in some embodiments astandard sterile drape may be used on the reusable portion before thedisposable portion is placed on the reusable portion.

Certain embodiments also divide the handheld instruments into reusableand disposable components. For example, the needle of an endoilluminatorinstrument or other instrument (for example, the instrument illustratedin FIG. 8A) that is inserted into the eye may be disconnected from therest of the handpiece, allowing the contaminated portion (for example,the needle) to be disposed of while the rest of the handpiece (which,for example, may be undesirable to dispose of because of cost or otherconsiderations) can be wiped down or otherwise sterilized, oralternately “bagged” or draped during the procedure to avoidcontamination. Likewise the needle(s) and aspiration fluidic componentsof a handheld vitreous or tissue cutter, soft-tip extrusion instrument,or lens removal device may in some embodiments be configured to bedisconnected from the rest of the handpiece for replacement with a newsterile component. Likewise a diathermy needle assembly may beconfigured to be disconnected from the rest of the handpiece to separatethe disposable from the reusable element.

Functional Interfaces

Various embodiments of surgical systems disclosed herein comprise one ormore functional interfaces to enable a disposable and/or sterilecomponent to functionally couple with a reusable and/or non-sterilecomponent. Such a functional interface may, for example, enable thereusable and/or non-sterile component to provide power, light, fluids,electronic communications, and/or various other functions to thedisposable and/or sterile component, enable the disposable and/orsterile component to perform one or more surgical functions. Severalexamples of functional connections or interfaces that may be utilizedbetween a sterile component and a non-sterile component are disclosedherein. For example. FIGS. 2A-2K, as further described below, illustratevarious mechanical rotational couplings. Such couplings may enable, forexample, a reusable motor or gearbox to couple with a disposable pumphead. FIGS. 3A-3C illustrate various functional interfaces in a customsurgical drape. The concepts illustrated may also in some embodiments beutilized in direct functional connections between a sterile componentand a non-sterile component. FIG. 4C illustrates an example of anelectrical functional interface that may be utilized with variousembodiments, including, for example, embodiments that utilize theelectrical interface to transmit electrical power and/or electroniccommunications. The embodiment illustrated in FIG. 4C illustrates anexample of using mating electrically-conductive contacts to provide apathway for electrical power and/or electronic communications. In someembodiments, however, power and/or communications are transmittedthrough non-contact or non-electrical means. For example, electricalpower may be transmitted in some embodiments using a wireless and/orinductive coupling. Communications may in some embodiments betransmitted wirelessly, through an optical coupling, and/or the like. Insome embodiments, a functional interface may comprise a transparent (orat least partially transparent) window, opening, or portion of a sterilecomponent (for example, openings 408 shown in FIG. 4E) that enables auser of the system to see an electronic display, light, and/or the likeof a reusable component. In some embodiments, an electrical functionalinterface comprises conductive connectors, an inductive interface,and/or the like. In some embodiments, an optical functional interfacecomprise light piping components and/or the like that enable transfer oflight from a reusable component to a disposable component. In someembodiments, a functional interface comprises a fluidic connector toenable fluid to be transferred from or to a reusable component.

In some embodiments, an interface between a sterile disposable tray (ora component of the tray) and a non-sterile reusable component or modulecan be one or more of the following: electrical; mechanical; optical;fluidic; and/or the like. An electrical functional interface may in someembodiments comprise single or multi-conductor connectors (for example,as illustrated in FIG. 4C), springs or spring contacts, “gold finger”connectors, edge connectors, and/or the like. An electrical interfacemay also be accomplished in some embodiments through an inductive orwireless link. An electrical interface may also in some embodimentscomprise single or multi-conductor cables or cords, jacks, plugs, and/orthe like. An electrical interface (or other type of functionalinterface) may in some embodiments be designed such that electricalcontacts on a disposable tray (or component thereof) and electricalcontacts on a reusable module are aligned by mechanical features on thetray and/or the module. The reusable module may also in some embodimentsconnect via a wired or wireless interface with externally locatedcomponents, such as a footpedal, externally located power supply, orseparate surgical console.

A mechanical functional interface may in some embodiments comprise acoupling between a reusable motor and a disposable pump head (forexample, comprising a peristaltic pump rotor, rollers, and tubing, asillustrated in FIG. 18) or reusable pump head and disposable peristaltictubing (wherein, for example, a surgeon or other user would stretch orotherwise install single-use or limited-use peristaltic tubing over areusable pump head). A mechanical interface may also in some embodimentscomprise a motor or other actuator connected to a belt, chain,transmission coil, torque coil, rotary cable, and/or the like foractuating a non-adjacent system such as, for example, a handheldinstrument. In some embodiments, the interface between the motor oractuator and its mating component may be a mechanical linkage orcoupling such as a spline coupling, spider coupling, shaft coupling,etc. Some examples of rotary mechanical couplings are illustrated inFIGS. 2A-2K, as described below.

An optical functional interface may in some embodiments comprise acoupling between a reusable light source and a disposable fiber, fiberbundle, light pipe, and/or other waveguide. The light source may in someembodiments be an LED (in some embodiments, either RGB or white) orwhite light lamp for endoillumination, a treatment laser (for example,532 nm or 1064 nm photocoagulation), or an imaging laser (for example,for optical coherence tomography). The interface may in some embodimentscomprise lenses, mirrors, fibers, fiber bundles, prisms, light pipes andwaveguides, and/or other optical elements to help guide and couple thelight from the reusable portion to the disposable portion of the system.

A fluid functional interface may in some embodiments comprise aninterface between disposable flexible tubing and a reusable sensor (forexample, pressure sensor, flow sensor, fluid sensor, and/or the like) orbetween disposable flexible tubing and a pneumatic or fluidic sourcesuch as a compressor, compressed gas, pressurized liquid, pump, and/orthe like. The interface may in some embodiments comprise fluidconnectors that are mated when the reusable and disposable componentsare coupled, combined, or otherwise placed in a desired position withrespect to each other.

In some embodiments, a sterile disposable tray (or a component thereof)may comprise an optical functional interface comprising a transparent orpartially transparent material, for example to enable viewing by a userof one or more displays that are integrated into the reusable module. Insome embodiments, the sterile disposable tray (or a component thereof)may comprise a thin, flexible, or otherwise pliable or compliantmaterial, configured to enable the user to activate buttons located onthe reusable module through the sterile disposable tray. In someembodiments, a sterile disposable tray may comprise thin vacuum formedplastic, and/or the like. In some embodiments, portions of thetransparent material may be painted, dyed, or otherwise made opaque,such that only a portion of the material (such as at the opticalinterface) remains transparent in use.

Any of the functional interfaces disclosed herein may be configured orpositioned to be automatically engaged or placed in a desired positionor configuration when the reusable component is coupled to thedisposable component (or otherwise placed in a desired position relativeto the disposable component). Alternatively, one or more functionalinterfaces may be configured to be manually engaged by a user before orafter the reusable component is coupled to the disposable component.

In some embodiments, a reusable portion(s) and/or disposable portion(s)may comprise features that help align, register, or otherwise positionthemselves to aid in mating or interconnecting the portions and/or theirfunctional interfaces. For example, one or both portions may includefeatures to help align or connect electrical contacts or interconnects,mechanical interconnects (for example, between a reusable motor shaftand disposable peristaltic pump rotor, cam, and/or the like, or betweena reusable pump rotor and rollers and disposable peristaltic tubing),pneumatic or fluidic interconnects (for example, to connect disposableportions to reusable sensors, pneumatic or fluid sources, compressedgases, peristaltic pumps, venturi pumps, and other pumps, and/or thelike) and/or optical interconnects (for example, to connect disposableportions to reusable light sources, lasers, and/or the like). Magnetsmay also be used in some embodiments to align or secure differentcomponents of the system. A reusable module may in some embodiments bepowered on or otherwise activated or enabled automatically or have ameans to determine that it is properly “docked” when installed within ormounted to (or otherwise coupled with) the sterile disposable tray (or acomponent thereof).

Surgical Tray Console

FIGS. 1A-1F illustrate an embodiment of a surgical tray 10 that may beused for an ophthalmic surgical procedure. FIG. 1A illustrates anoverhead or top view of the surgical tray 10 in use with a patient 2. Inthis embodiment, the surgical tray 10 comprises a void or cutout 102shaped to be positioned around the patient's head. FIGS. 1B-1F furtherillustrate the surgical tray 10 and one way the surgical tray 10 may bemounted to a surgical table, chair, or gurney 13. In some embodiments, asurgical table 13 as shown in FIG. 1C comprises a support 12, such as awrist support, shown in more detail in FIG. 1B. The support 12 comprisesa support bar 16 and an end 14 configured to connect to a head of thesurgical table 13. As shown in FIG. 1E, in some embodiments, a surgicaltray 10 may comprise a top portion 101 configured to mate with a baseportion 104. In the presently illustrated embodiment, the base 104 isdesirably intended as a mounting structure to enable efficient andconfigurable mounting of the top portion 101 to the table 13. In someembodiments, as further described herein, a base portion may comprisemore functional features, such as, for example, a motor and/or pump,electronics, and/or the like. The base 104 may comprise one or moreslots 106 or other features configured to enable the base 104 to attachor couple to the support 112 of the table 13. In some embodiments,straps are used to hold the base 104 to the support 112, with the strapspassing through the slots, grooves, or recesses 106. In someembodiments, the surgical tray 10 comprises a pad 108 positioned on topof the base 104 to, among other things, help remove any slack betweenthe top portion 101 and the base 104 to maintain a sturdier connectionbetween the top portion 101 and base 104.

As can be seen in FIG. 1F, in some embodiments, a surgical tray isconfigured to slidably engage a base. In this embodiment, the surgicaltray top portion 101 comprises latches 126 which engage the base 104. Insome embodiments, levers or switches or handles 124 enable a user of thesurgical tray 10 to selectively engage or lock the top portion 101 inposition with the base 104. In some embodiments, the latches 126 areadjustable to enable the top portion 101 to lock in a plurality ofpositions, such as to accommodate patients of different sizes and/or apreference of the user. For example, in the embodiment illustrated inFIG. 1F, which is a bottom view of the surgical tray 10, the top portion101 is illustrated locked in place in a position approximately halfwayto a full engagement position.

FIG. 1E, which is an exploded view of the top portion 101, base 104, andsupport 112, illustrates several features of the surgical tray 10. Forexample, the surgical tray 10 comprises one or more handpieces orsurgical tools 110, in this embodiment four handpieces 110. Thehandpieces 110 may comprise one or more tools for performing surgicalfunctions, such as, for example, vitreous cutting, diathermy orelectrocautery, illumination, and/or the like. In some embodiments, thehandpieces 110 are tethered to the top portion 101 through cables ortethers 112. In some embodiments, a cable or tether 112 comprises one ormore features, such as, for example, power transmission, electroniccommunication, communication through other methods, such as pneumatic oroptical, and/or the like.

The surgical tray 10 further comprises a plurality of recesses orstorage structures 111 configured to engage the handpieces 110 to holdthe handpieces in place until they are needed and/or between surgicalprocedures. The surgical tray 10 further comprises a plurality ofcontrols 114 to control a plurality of functions of the surgical tray10, such as, for example, fluid infusion, oil infusion, air infusion,and/or the like. The surgical tray 10 further comprises a power button116 configured to operate power to one or more devices of the surgicaltray 10. One or more displays or indicators and/or light sources 118 ofthe surgical tray 10 enable information to be communicated to, forexample, a user or surgeon during a surgical procedure. In someembodiments, one or more displays or indicators 118 may be locatedseparate from the surgical tray 10, for example on the microscope or onthe wall and connected to the tray via a wired or wireless connection.The surgical tray 10 further comprises a fluid reservoir receiver 120and a balanced salt solution (BSS) bottle, container, sterile enclosure,or other holder 122. In this embodiment, a motor may be configured to beremovable and/or removably coupled to a pump head 123, shown in FIG. 1F.The pump head further comprises pump input and/or output tubes 123. Insome embodiments, it may be desirable to make a motor removable from thesurgical tray 10 and/or pump head 123, so that, for example, arelatively expensive and/or higher-quality motor may be utilized, whilea rest of the surgical tray 10, including the pump head 123, isdisposable after a single procedure or a predetermined number ofprocedures. Various embodiments of coupling mechanisms that may be usedto couple the motor to the pump head 123 are described in further detailbelow with reference to FIGS. 2A-2K.

In some embodiments, one or more surgical trays disclosed herein, suchas, for example, the surgical tray 10 illustrated in FIGS. 1A-1F, maycomprise one or more features similar to and/or one or more featuresthat may operate similarly to those disclosed in U.S. Pat. No.8,568,391, entitled STERILE SURGICAL TRAY, which is hereby incorporatedby reference herein in its entirety.

Different embodiments may comprise removable and/or non-removableelectronics that control the functions of the tray. The electronics maycomprise one or more microcontroller(s), microprocessor(s),microelectronics, and/or the like; the electronics may include any of avariety of sensors, including but not limited to pressure, vacuum, flow,temperature, light intensity, voltage/current/power, and inertialmeasurement. The electronics may also be designed to be low cost andtherefore disposable after a single use or a limited number of uses. Theelectronics may comprise software or hardware features that prevent theuse of the electronics beyond what was intended by the manufacturer. Forexample, the electronics may become inoperable after a single use toprevent reuse which can pose a safety risk to the patient (for example,because the system is no longer sterile) and protect sales revenue forthe manufacturer. The electronics may also in some embodiments bedesigned to work for a limited number of uses, a limited amount of time,or until a pre-defined expiration date. For example, this would beuseful to prevent the use of the system beyond what is consideredreliable (for example, certain components may have a limited number ofuses before the probability of failure becomes a risk, or the efficacyor sterility of certain components of the system may have a limitedshelf-life). This could also be used in a subscription-style salesmodel, wherein the surgeon or hospital can purchase additional creditsto use the system for additional surgical procedures or add/unlockadditional functionality of the system. Some embodiments may alsoutilize non-electronic and non-software means of limiting reuse; forexample the handpieces and/or tray components may be manufactured frommaterials that do not survive autoclave sterilization.

A tray in some embodiments may incorporate an internal power supply ortransformer and rectifier that converts AC wall power to lower voltageDC. The tray may alternatively utilize a power supply separate from thetray (e.g. a “wall-wart” transformer or external brick power supply).The tray may also be powered by one or more single-use (primary)batteries (for example, alkaline, lithium manganese, or other chemistry)or rechargeable (secondary) batteries (for example, Li-ion, Li-Poly,NiMH. NiCd, or other chemistry). The batteries may, in some embodiments,be configured as a self-contained battery pack that can be removed fromthe tray itself. The tray may also derive power (electrical, pneumatic,and/or otherwise) from a separate console system to which the tray iscoupled or from the surgical microscope.

In embodiments that comprise a reusable permanent or semi-permanent basethat is separate from the tray itself, the base may be designed toincorporate any one or several of the following for benefits thatinclude reducing the manufacturing cost of the tray, reducing waste, andusing higher quality reusable components: electronics; displays; sensors(e.g. pressure, flow); power supply; one or more primary or secondarybatteries or battery packs; pumps or components and sub-assemblies of apump (e.g. the motor and drive circuitry) for example to be used forinfusion, aspiration, and/or driving a pneumatic or hydraulicinstrument; handpiece drive motors (e.g. for moving or rotating atransmission cable or torque coil connected to a vitreous cutter orother mechanical instrument); endoillumination light source;photocoagulation laser. The base and tray may implement features thatallow the tray to be temporarily but reliably attached to the base, aswell as to adjust or otherwise translate the position of the tray, forexample to accommodate different patient geometries. In yet anotherembodiment, some or all of these features may be located in a footpedal(or more than one footpedal) that is used to control the functions ofthe surgical tray and handpieces. The footpedal may be tethered to thetray and/or handpieces through electrical connections (e.g. a cableassembly), pneumatic/hydraulic connections (e.g. tubing), opticalconnections (e.g. one or multiple optical fibers for broadband or narrowwavelength light that can be used for illumination, laser therapy,imaging, etc.), and mechanical linkage connections (e.g. transmissioncables or torque coils for transferring the motion of a motor, piston,etc. located in the footpedal enclosure to the tray or handpieces.) Inrelated embodiments, the footpedal may contain some of these elementsbut connect to pumps (e.g. for infusion and/or aspiration) that arelocated in the base unit or tray such that the tubing lengths betweenthe pump and the patient are minimized.

In embodiments with pump motors and/or handpiece drive motors in aseparate base, the pump motors may couple to the pump heads in the trayand the drive motors may couple to the transmission cable or torque coilvia spline couplings, shaft couplings, or similar that are aligned andengage when the tray is mounted or positioned on the base. FIGS. 2A-2Killustrate a variety of embodiments of couplings or coupling mechanisms205 that may be configured to enable removable coupling of a motoroutput shaft and/or torque transfer mechanism 204 to a pump head 202.The embodiments illustrated herein comprises a pump-side couplingportion 206 and a motor-side coupling portion 208. In the embodimentsillustrated in FIGS. 2A-2C, the pump-side coupling portion 206 comprisesa male spline configured to couple with a female spline of the motorcoupling portion 208. The male splines 206 are configured to slidablycoupled with the female splines 208 to enable a torque to be transferredfrom the motor to the pump head 202. FIG. 2D illustrates an embodimentof a coupling 205 wherein a male portion 206 and a female portion 208comprise mating flats, similar to a hex head bolt and socket that enabletransfer of torque therethrough. FIGS. 2E-2K illustrate a variety ofembodiments wherein alternating peaks and voids of a pump-side portion206 engage alternating peaks and voids of a motor-side portion 208 toenable transfer of torque therethrough. Various other removable torquetransfer couplings may alternatively be used. In other embodiments, thepump motors and pump heads are not readily separable and instead thepump tubing is separable from the pump head.

Functional Sterile Barrier

In some embodiments, an ophthalmic surgical system comprises a customsterile barrier, such as a drape, that can be used to drape thenon-sterile permanent base to create a sterile barrier before placingthe tray on the base. The drape may in some embodiments be form-fittedto the base and tray. The drape may in some embodiments comprise one ormore functional features, such as one or more features enabling light,electricity, a mechanical device, and/or the like to pass therethrough.For example, the drape may comprise one or more transparent windows toenable displays in the base to be viewed. In some embodiments, the drapemay comprise perforations that are broken or pierced when the tray ismounted to the base to enable electrical, mechanical, and/orfluidic/pneumatic connections to be made between the tray and the base.In some embodiments, the drape may lack any perforations but nonethelessbe punctured or perforated in specific areas when the tray and the baseare mated. In some embodiments, the tray and the base may form a sealaround the area to be perforated before the perforation occurs to ensurethat a sterile barrier is maintained during the setup process. In someembodiments, the drape may have integrated electrical contacts such thatone or more electrical connections can be made between the base and thetray without breaking or piercing the drape or otherwise compromisingthe sterile barrier. These electrical contacts may be formed, in someembodiments, by integrating separate contacts into the drape material,or the drape material itself may be made of a material or incorporate amaterial in the appropriate regions that is anisotropically conductive,such that electrical current can flow through the thin drape materialbut multiple adjacent current paths do not interact with each other. Inother embodiments, electrical power is wirelessly transferred throughthe drape via inductive coupling of two antennas located on oppositesides of the drape or via similar wireless power transmission methods.

FIG. 3A illustrates a top view of an embodiment of a drape 300incorporating a plurality of functional features. Drape 300 comprises asheet of flexible material 302 configured and/or shaped and/or sized tobe draped over, for example, a base portion of a surgical tray and or apatient's head to enable maintaining a sterile barrier during surgery.In some embodiments, the drape is configured to be positioned at leastpartially between a base portion and a top portion of a surgical tray,such as is illustrated in FIG. 4F, as further discussed below. In theembodiment illustrated in FIG. 3A, the drape 300 is illustrated as arectangle for simplicity; however, in other embodiments, the drape 300may be shaped differently and/or custom-fitted such that the drape isable to be positioned in a predetermined configuration over at least aportion of a surgical tray.

The drape 300 comprises two windows 304, such as transparent regionspositioned to enable a user to view one or more displays of a surgicaltray therethrough. For example, the windows 304 may be positioned toenable a user to view the displays 118 illustrated in FIG. 4A, asfurther described below. The drape 300 further comprises a perforatedarea 306 comprising a perforation enabling the perforated area 306 to bebreached and/or removed when the drape 300 is placed into position,enabling a functional device to pass therethrough. For example, anelectrical connection may pass therethrough, a mechanical coupling maypass therethrough, a pneumatic and/or hydraulic coupling may passtherethrough, an optical coupling may pass therethrough, and/or thelike. The drape 300 further comprises an alternative perforationconfiguration 308. The perforation 308 comprises a perforation in theshape of a cross, such as to enable a tubular or other functional memberto pass therethrough.

In some embodiments, one or more functional areas of a drape 300comprise a sealing portion 310, shown in FIG. 3A as a circular areaaround the perforation 308. The scaling portion 310 may comprise, forexample, a material that enables or aids in forming a sterile sealbetween, for example, a top portion and bottom portion of a surgicaltray prior to the perforation 308 being breached or torn or opened. Insome embodiments, the sealing portion 310 may comprise a resilientmaterial, such as a rubber. In some embodiments, the sealing portion 310comprises a ring of material (or otherwise shaped) that is stiffer thanthe primary drape material 302.

In some embodiments, the drape 300 comprises an electrical contactportion or region or block 312. The electrical contact portion 312 inthis embodiment comprises a plurality of electrical contacts 314, suchas electrically conductive material that enables a mating contact on oneside of the drape 300 to be in electrical communication with a matingcontact on an opposite side of the drape 300. FIG. 3B illustrates across section of the electrical contact portion 312. It can be seen inFIG. 3B that, in this embodiment, the plurality of electrical contacts314 pass from one side of the drape 300 to another side of the drape300, thus enabling electrical current to pass also from one side of thestreet 300, such as a sterile side, to another side of the drape 300,such as a nonsterile side.

FIG. 3C illustrates a cross section of an alternative embodiment of anelectrical contact portion 312′. In this embodiment, the electricalcontact portion 312′ comprises an anisotropically conductive materialthat, as illustrated schematically in FIG. 3C, enables electricalcurrent to pass in one direction, such as from one side of the drape 300to another side of the drape 300, but not in a transverse orperpendicular direction. Accordingly, a plurality of electrical contactsof a top portion of a tray may be configured to be in electricalcommunication with a plurality of electrical contacts of a bottomportion of a surgical tray through the electrical contact portion 312′without requiring a plurality of discrete electrical contacts on theelectrical contact portion. This may, among other things, enable reducedmanufacturing costs and/or an increased tolerance of positioning of thedrape with respect to the surgical tray.

Modular Surgical Tray System

In some embodiments, a surgical tray as disclosed herein may be amodular system, with a base or reusable portion that is configured tohave one or more modules coupled to it. In some embodiments, a baseportion is configured to be reusable, at least for a predeterminednumber of procedures and/or length of use, while one or more inembodiments of modules are configured to be disposable, such as after asingle use. In some embodiments, a module surgical tray system comprisesa disposable top tray portion that couples to a reusable bottom trayportion. In some embodiments, a modular surgical tray system comprises areusable tray having one or more locations for insertion of one or morefunctional modules, such as a motor/pump module, a fluid reservoirreceiver module, a power adapter module, a modular tool insertcomprising one or more handpieces, and/or the like.

In some embodiments, a reusable portion of a modular surgical traysystem, such as a base portion, comprises one or more reusablefunctional units configured to couple to, communicate with, and/or thelike, one or more disposable functional units of one or more modules.For example, in some embodiments, a reusable base portion may comprise amotor that is configured to couple with a disposable pump housing of adisposable module portion. In some embodiments, a reusable portion, suchas a base portion of a surgical tray system or assembly, may comprise anelectrical processing unit configured to control operation of one ormore surgical tools and/or to detect inputs or conditions from one ormore controls and/or surgical tools of a disposable portion. In someembodiments, a modular surgical tray system comprises a custom surgicaldrape, such as described above with reference to FIGS. 3A-3C, that isconfigured to be positioned between a reusable or base portion and adisposable or top portion or module.

FIG. 4A illustrates a perspective view of an embodiment of a modularsurgical tray system comprising a top or disposable portion 402 coupledwith a bottom or reusable portion 404. The bottom portion 404 is coupledto a support 112, such as a support at a head of a surgical table. Thebottom portion 404 may be configured to mate with the support 112 in avariety of ways, such as, for example, straps that pass through slots,such as the straps 412 illustrated in FIG. 4B. The surgical tray 410illustrated in FIG. 4A comprises a plurality of features similar indesign to those of other embodiments described herein, such as, forexample, a plurality of handpieces 110, storage or support locations forthe handpieces 111, a plurality of tethers or cables 112 connecting thehandpieces 110 to, in this embodiment, the bottom portion 404, aplurality of controls 114, a power button 116, two displays 118, a fluidreservoir receiver 120, and a BSS bottle 122. The embodiment illustratedin FIG. 4A additionally comprises a foot pedal 406 tethered to or incommunication with the bottom portion 404 to enable control of one ormore features of the surgical tray system 410.

FIG. 4B illustrates an exploded view of the surgical tray system 410showing the base portion 404 attached to the support 112, but the top ordisposable portion 402 not yet coupled to the base portion 404. In thisembodiment, some functional features of the base portion 404 areillustrated, including the displays 118, a light source 418 (in thisembodiment an LED and in other embodiments the light source can be alaser, halogen lamp, or the like), and two pumps 414. FIG. 4Cillustrates another example of a functional feature that enableselectrical connection between the top portion 402 and the base portion404. In this embodiment, the tethers or cables 112 are connected to atop electrical connector 418 that is part of or coupled to thedisposable tray portion 402. The top connector portion 418 comprises aplurality of electrical contacts or pins 419 protruding therefrom andconfigured to engage mating electrical contacts 421 of a bottomconnector portion 420 that is part of or coupled to the base portion404. Accordingly, in this embodiment, the handpieces may beautomatically connected to electronics or other features of the baseportion 404 upon coupling of the top portion 402 to the base portion404. In other words, a user of the system may not have to individuallyplug-in each handpiece after positioning the surgical tray top portion402 over the base portion 404. In some embodiments, such a configurationcan be advantageous to enable, for example, more expensive and/ordurable components to be part of or coupled to the base or reusableportion 404, while the top or disposable portion 402 may be supplied asa single sterile assembly ready to be utilized for a single surgery anddisposed of after surgery.

FIG. 4D illustrates a top view of the surgical tray system 410. FIG. 4Eillustrates a bottom perspective view of the top or disposable portion402 of the surgical tray system 410. The view in FIG. 4E illustrates inmore detail openings 408 for viewing of the displays 118, and a driveportion 204 of the motor 122A, such as a coupling configured tomechanically coupled to a pump head coupled to a BSS bottle 122. In someembodiments, as described above, the motor 122A may be configured to bereusable and/or may be configured to be removable from the top ordisposable portion 402 for use with another disposable portion 402.

FIG. 4F illustrates a fully assembled view and an exploded view of thetop or disposable portion 402 of the surgical tray system 410 beingpositioned over the bottom portion 404 with a drape 430 positionedtherebetween. It can be seen in FIG. 4F that the drape 430 comprisesdisplay windows 432 enabling viewing of displays of the bottom portion404 through the drape 430. The drape 430 may further comprise one ormore additional functional interfaces, as described above with referenceto FIGS. 3A-3C.

FIG. 5A illustrates another embodiment of a modular surgical tray system510 comprising a top or disposable portion 502 coupled to a bottom orreusable portion 504. The modular surgical tray system 510 is similarfunctionally to the modular surgical tray system 410 described above,but with a different layout of and/or design of some of the features.Various elements of the surgical tray system 510 utilize similarreference numerals to represent features similar to those of thesurgical tray system 410. FIG. 5B illustrates a top view of the surgicaltray system 510 wherein the handpieces have been removed, illustratingthe full handpiece support or storage locations 111. Further, the BSSbottle 122 has been removed, showing more detail of the motor receivingpocket or area 502.

FIGS. 6A-6F illustrate another embodiment of a modular surgical traysystem 610. In this embodiment, the modular surgical tray system 610comprises a reusable or base portion 650 having a plurality of locationsor interfaces configured for acceptance of or coupling to one or moremodules. In this embodiment, the system 610 comprises a motor and pumpmodule 622, a fluid reservoir receiver module 620, a power adaptermodule 654, and a modular tool insert 652. In an embodiment, the motorand pump module 622 can comprise a BSS bottle holder. In an embodiment,the motor and pump module 622 can comprise drive electronics for theinfusion pump and/or the pressure sensor. In an embodiment, the driveelectronics and/or the pressure sensor can be located in the reusableportion of the tray. In an embodiment, the fluid reservoir receivermodule 620 can comprise the aspirated fluid reservoir and the aspirationpump. In an embodiment, the fluid reservoir receiver module 620 cancomprise the drive electronics for the aspiration pump and the pressuresensor (or one or both of these may be instead located in the reusableportion of the tray). In an embodiment, the power adapter module 654 canbe incorporated into one of the displays. In an embodiment, the poweradapter module 654 can be located underneath the tray (in the reusableportion) or elsewhere (for example, on the ground, or the like). FIG. 6Billustrates a side view of the motor and pump module 622 (or in someembodiments a BSS bottle holder 622). FIG. 6C illustrates a side view ofthe fluid reservoir receiver module 620. FIG. 6D illustrates aperspective view of the motor and pump module 622 (or in someembodiments a BSS bottle holder 622), the fluid receiver module 620, andthe modular tool insert 652, such as may come as a sterile package orassembly ready for use in a sterile operating environment. In thisembodiment, it can be seen that the modular tool insert 652 comprises afolding or hinged joint 653 enabling the insert to be folded upon itselfto reduce an overall package size of the insert, for example, to reducea size during storage or shipping.

FIG. 6E illustrates a perspective view of the base portion 650 withoutthe BSS holder, fluid receiver, or tool insert modules coupled thereto.The base portion 650 comprises a fluid receiver interface 621 shaped orconfigured to couple with the fluid receiver module 620, and a motorinterface 623 (or BSS interface 623) configured or shaped to couple withthe motor and pump module 622 (or BSS module 622). The base portion 650further comprises two tool insert interfaces 653 comprising recessedareas for locating and/or retention of the tool insert 652. FIG. 6Afurther illustrates straps 412 configured to retain the base portion 652to a support 112. In some embodiments, the straps 412 (or anotherportion of the base 650) may comprise a feature that helps to retain themodular tool insert 652 to the base portion 650, such as a hook and loopfastener, a magnet, and/or the like. FIG. 6F illustrates an explodedview of the modular surgical tray system 610.

In the example embodiment illustrated in FIGS. 6A-6E, the reusableportion 650 comprises a base that mounts directly or indirectly to thesurgical bed or chair. The reusable portion 650 may compriseelectronics, displays, motors, pumps, compressors or compressed gassources, sensors, light sources, power supplies, batteries, and/or thelike. The disposable portion 652 may comprise a tray that may be foldedor hinged in half (for example, a vacuum formed or molded plastic tray)and upon opening, unfolding, or removal from packaging can be placedinto the reusable tray 650, either directly or with a sterile drapebetween the two. The disposable tray 652 may comprise handpieces 110,fluidic components, optical components, pumps, electronics, motors andactuators, and/or portions of these or other components. The disposabletray 652 may in some embodiments be mounted or attached to the reusableportion 650 with aligning features, cutouts, wells, pockets, magnets,and/or the like.

In other embodiments, the reusable base 650 incorporates fewer or noactive components (for example, electronics, displays, motors, pumps,compressors or compressed gas sources, sensors, and/or the like) butsimply provides structural support to the disposable tray 652 (and/orBSS bottle and reservoir modules 622, 620). The reusable tray 650 may insome embodiments be draped with a standard drape to provide a sterilebarrier upon which the disposable tray 652 is placed, since nofunctional interfacing is required through the drape in an embodimentwhere the reusable base 650 incorporates no active or functionalcomponents. In such a case, the reusable tray 652 may include features(for example, similar to those described below with reference to FIGS.12A-12C and 13A-13C) to accommodate a reusable functional module, forexample within a cavity isolated from the sterile environment.

Additional components may also be present in other related embodiments.For example, modular components 620, 622 (either disposable or reusable)as shown in FIGS. 6A-6F can be placed into the reusable tray 650. Insome embodiments, the infusion function and aspiration function areseparated into separate modules 620, 622 that include a portion of orsubstantially all components required for either function. In FIGS.6A-6F, the aspiration and infusion modules 620, 622 are two distinctmodules that share the same form factor and can be installed on eitherside of the reusable tray 650. This can be beneficial, for example, toenable placement of the infusion module 622 adjacent to the eyeundergoing the surgical procedure and possibly using the opposite spaceto hold the aspiration module 620 or other functional component ormodule.

FIG. 6F shows an example of unfolding the disposable tray 652 (forexample injection molded or vacuum formed) that is placed or otherwisesupported on a reusable or separate disposable part 650, possiblyseparated by a sterile drape, bag, or similar. The unfolded disposabletray 652 may in some embodiments align on the bottom reusable part 650through various aligning features or magnets for example, as furtherdiscussed with respect to other embodiments disclosed herein. Thefoldable disposable tray 652 may include handpieces 110 and/or it mayalso contain other functional elements such as an aspiration functionmodule and/or infusion function module (including some or all of thefollowing: pump, motor, pump head, fluid reservoir tank, electronics,fluidic components including tubing, filter(s), stopcock(s), fluidconnector(s), and/or the like). Alternately, in some embodiments, someor all of the functional modules can be separate from the disposabletray portion 652 that holds the handpieces 110.

The tray in some embodiments may also be designed to connect to orotherwise mate with a separate surgical console. The tray and consolemay share electrical, mechanical, pneumatic, hydraulic, wireless, orother interfaces with each other. For example, in some embodiments thetray may provide a “docking station” or hub for the handpieces that canbe conveniently located near the patient. This hub can be connected tothe separate surgical console (electrically, pneumatically, and/or thelike) and distribute the power (electricity, illumination,pneumatic/compressed air, hydraulic, mechanical, and/or the like) to theappropriate handpieces. The tray can also in some embodimentscommunicate information to the console, for example to control the powersources (voltage, current, pneumatic pressure, light intensity, and/orthe like) and/or to display information on the surgical console'sdisplay.

The tray may also be designed in some embodiments to connect, mount, orotherwise mate to a surgical microscope or portion thereof. For example,the tray may be mounted to the optical head of the surgical microscopeso that it hangs adjacent to the surgical site, or the tray may bemounted to the base or upright section of the microscope so that it ispositioned adjacent to the surgical site. The tray may also be designedin some embodiments to tether power (electrical, laser, illumination,pneumatic, hydraulic, or other) and/or other functionality (e.g. datacommunication) from the microscope or a module connected to or mountedon the microscope.

Configuration of Profiles

The tray and/or base unit may also in some embodiments comprise a methodof enabling the user to load specific settings and/or a user profile.For example, the tray or base may in some embodiments comprise awireless RFID reader or near field communication (NFC) link that reads a“tag” (e.g. located on the user's ID badge) which is programmed with theuser's preferences such as aspiration and infusion ranges, buttonfunctions, handpiece settings, and/or the like. In some embodiments, thetag comprises an identifier associated with the user's preferences,instead of the tag itself being programmed with the user's preferences.In some embodiments, the system is configured to automatically apply auser's preferences and/or to load settings associated with a specificuser or tag when the tag is read by the wireless reader. In someembodiments, the tray comprises an antenna portion of the wirelessreader, and the base comprises another portion of the wireless reader,such as a processing unit, which can be electrically connected to theantenna portion when the tray is connected to the base. Such a designcan be advantageous to enable a more expensive portion of the wirelessreader, such as the processing unit, to be reusable. The tray and/orbase unit may in some embodiments comprise a USB or memory cardinterface or similar means of allowing the user to transfer informationto the tray or base to, among other things, load or set settings and/ora user profile.

FIG. 7 illustrates a top view of a surgical tray 710 similar in designto the surgical tray 10 illustrated in FIG. 1A. The surgical tray 710,however, further comprises an antenna 702 configured to communicatewirelessly with a tag, near field communication device, and/or the liketo enable configuration of parameters, user preferences, and/or thelike. In some embodiments, the antenna 702 may be electrically coupledto a processing unit to enable the processing unit to configure theparameters, preferences, and/or the like.

Surgical Tray Components/Functions

A surgical tray in various embodiments can be configured to provide oneor more of a multitude of components and/or functions for performing asurgical procedure. In addition to components and functions describedabove, the components and/or functions may comprise, but are not limitedto: infusion, aspiration, one or more handpieces, illumination, lasertherapy, display, audio feedback, one or more footpedals, and storage.These components and functions are described in greater detail below.

Infusion

The tray in some embodiments may provide infusion of fluids (balancedsaline solution aka BSS and other fluids, including silicone oil,viscoelastic gels, dyes/stains, and/or the like) and/or gases into theeye, either the posterior or anterior chamber, for example by using ahandpiece, such as one of the various handpiece embodiments disclosedherein. The infusion source (for example, a bottle or bag) may include alight (for example, an LED) to illuminate fill level, preferably but notnecessarily the color red to minimize the impact on the surgeon's lowlight vision. The infusion fluid pathway may comprise in someembodiments a pressure and/or flow sensor to determine infusion and/orintraocular pressure and/or infusion flow rate. The fluid pathway andsensor may in some embodiments be separated by a filter or membrane toprevent contamination of the fluid and/or damage to the sensor, or insome embodiments non-contact measurement methods may be utilized. Thetray may comprise in some embodiments a means of holding or securing theinfusion fluid bottle or bag, such as a cup-holder or hook and/or thelike, and a spike, needle, or fluidic attachment for extracting thecontents of the bottle or bag. The tray may comprise one or moreinfusion systems to provide infusion for different fluids or gasessimultaneously, on demand, or in a particular order. The tray maycomprise stopcocks or other valves (manual or automated) to enableselection between different infusion sources (e.g. BSS or oil) orinfusion locations (e.g. an infusion port next to the left eye vs. aninfusion port next to the right eye).

In some embodiments, the tray may comprise multiple infusion systems,for example two separate systems located on opposite sides of the tray,each system designated for use with the adjacent eye. This can beadvantageous to help ensure the tubing length from the infusion systemto the patient's eye is minimized. The tray may also in some embodimentscomprise multiple infusion systems (e.g. one for BSS and one forsilicone oil) that are optimized for different viscosity fluids. Inpreferred embodiments, the total tubing length or fluid path length fromeither the infusion source (e.g. BSS bottle) or the infusion pump to theinfusion cannula (which is inserted into the patient's eye) isminimized. Minimizing this fluid path length can improve the overallperformance of the infusion system. The responsiveness of an infusionsystem that is actively maintaining an intraocular pressure level (e.g.via feedback control) during a surgical procedure is directly related tothe length of the tubing set connecting the infusion source or infusionpump to the eye. Infusion systems with longer tubing sets, as is typicalin commercially-available ophthalmology surgical consoles that are notlocated immediately adjacent to the patient, result in an undesirablelag or delay when measuring or adjusting the intraocular pressure ascompared to those with shorter tubing sets. The infusion cannula canalso be primed faster (before insertion into the patient's eye) in aninfusion system with short tubing sets. In a preferred embodiment, thislength (either source to cannula or pump to cannula) will not exceed 24inches, but additional embodiments may be utilized that allow thislength to reach 36 inches or more.

In one embodiment, the tray system comprises a separate infusion systemfor injecting silicone oil and similar viscous fluids. The oil infusionsystem may be a separate module that is utilized only in surgical casesthat require oil infusion. The oil infusion system may be connected to ahandpiece connector in order to supply power to the oil infusion systemand provide a communications interface between the oil infusion systemand the tray or base electronics. In some embodiments, the oil infusionsystem is designed as a handpiece with an endoscopic needle or tube thatis used to infuse the oil or fluid into the eye. In other embodiments,the oil infusion system interfaces to the infusion cannula alreadyinserted in the eye for BSS infusion. The infusion of oil may be donemanually (for example, by depressing or squeezing a plunger and/or thelike), it may be done pneumatically or hydraulically (for example, usinga separate pump, compressor, compressed gas source, and/or the like), orit may be done electromechanically, for example with a motor, solenoid,or similar actuator that can infuse the oil (for example, aballscrew/leadscrew, Hamilton syringe type configuration that moves aplunger to expel the oil from a syringe or cartridge, and/or the like).

Some embodiments utilize a pump or other means to provide fluidinfusion. The pump style may be a standard Venturi, peristaltic, ordiaphragm design, or another standard or non-standard pump variety. Theinfusion system may in some embodiments rely on other mechanisms ofaction to achieve fluid infusion, for example a fluid-filled syringedepressed either manually (for example, by the surgeon or an assistant)or automated (for example, via a syringe pump mechanism, actuator,motor, servo, ballscrew/leadscrew, spring, and/or the like).

Some embodiments may be configured to use a manually or automaticallyadjustable pole to raise or lower the BSS bottle or bag, exploitinggravity to provide a variable infusion pressure related to the height ofthe fluid source.

Some embodiments may be configured to pump air into or out of the fluidbottle to control the infusion pressure and therefore intraocularpressure (forced gas infusion). Pumping gas into the bottle increasesthe infusion pressure, while drawing air out of the bottle via pumping,vacuum, or venting (for example, through a tube or needle whose intakeport is located above the water level) decreases the infusion pressure.Using this technique not only enables precise control of the infusionpressure but it also helps dampen pressure spikes and dips. Thepulsating flow output of a peristaltic pump can also be minimized whenusing the peristaltic pump to pump air into the fluid bottle to increaseinfusion pressure.

Some embodiments utilize a compressed gas, e.g. a nitrogen or other gas(preferably inert) filled cartridge, canister, or tank as a source ofpressure to enable fluid infusion (for example, via Venturi action orforced gas infusion). The cartridge, canister, or tank may bereusable/refillable or disposable and intended for single-use or limiteduse.

Some embodiments utilize a soft infusion fluid bag (as opposed to aglass or rigid plastic bottle). The soft bag may in some embodiments belocated in a fixture between two or more plates that can squeeze orotherwise exert pressure on the bag in one or more axes. The distancebetween the plates (and thus the squeeze force) can be controlledmanually by the surgeon or assistant or automatically, for examplethrough a mechanical system comprising one or more of an actuator,motor, servo, cam, solenoid, gear, ratchet, rack and pinion, band, belt,pulley, chain, and/or the like. Increasing the squeeze force increasesthe infusion pressure; decreasing the squeeze force decreases theinfusion pressure. Likewise, a similar mechanism can be used on asmaller container of infusion fluid, for example a reservoir into whichinfusion fluid drips or flows from the original infusion bottle or bag.A check valve can be included in some embodiments to prevent backflowinto the original bottle or bag. The soft bag may also be located in anair-tight rigid container, which can have air pumped in or out (orvented) to increase or decrease the pressure on the external surface ofthe bag. Since the bag is not rigid, but compressible, the infusionpressure can be adjusted by adjusting the pressure in the rigidcontainer. Likewise, a similar mechanism can be used on a smallercontainer of infusion fluid, for example a reservoir into which infusionfluid drips or flows from the original infusion bottle or bag. A checkvalve can be included to prevent backflow into the original bottle orbag.

In some embodiments the infusion fluid(s) are included in or integratedinto the tray system so that the tray and fluid are packaged,sterilized, and shipped as a single system that can be disposed of afterthe surgical procedure. This is in contrast to a system wherein the trayis packaged, sterilized, and shipped as a separate component than theinfusion fluid (e.g. BSS bottle) which may be from a differentmanufacturer altogether. Such a system may also include a separateadditional means of introducing infusion fluids into the fluidic path ofthe system, for example if the included fluids are exhausted during thesurgical procedure.

Aspiration

In some embodiments, the tray may provide aspiration functions, forexample from a vitreous cutter, soft-tip, or phaco handpiece. Theaspiration function may be provided through the use of a pump or byanother means. The pump style may be a standard Venturi, peristaltic, ordiaphragm design, or another variety. The aspiration pump system mayalso rely on other mechanisms of action to achieve vacuum draw at theneedle tip, for example a syringe with a depressed plunger connected tothe aspiration needle either directly or via a tube, the plunger beingdrawn back to produce a vacuum force, the action of being drawn backaccomplished either manually (for example, by the surgeon or anassistant to the surgeon) or through a semi-automated or fully automatedprocess (for example, a syringe pump mechanism, an actuator, motor,servo, ballscrew/leadscrew, spring, and/or the like), and/or the like.Some embodiments may utilize compressed gas (such as previouslydescribed), for example to generate a vacuum for aspiration throughVenturi action. The aspiration fluid pathway may in some embodimentscomprise a pressure or flow sensor to determine aspiration vacuumpressure and/or aspirated fluid flow rate. The fluid pathway and sensormay in some embodiments be separated by a filter or membrane to preventcontamination of the fluid and damage to the sensor, or non-contactmeasurement methods may be utilized.

In some embodiments, the tray may also incorporate a reservoir tank tohold the waste aspirated fluid and tissue. The tray may comprise awindow and/or a light (e.g. LED) preferably but not necessarily thecolor red to minimize the impact on the surgeon's vision, to enable tothe surgeon to visualize the fluid level in the reservoir tank. Thereservoir tank may in some embodiments comprise a fluid level sensor tomeasure the level of aspirated fluid and remaining free volume. This maybe utilized, for example, to alert the surgeon if the reservoir tank isnear full capacity. The reservoir tank in some embodiments may beconfigured to expand as the volume of fluid inside increases (forexample, as a balloon or bladder style reservoir, a reservoir withaccordion-style collapsible walls, and/or the like).

Locating the aspiration pump and waste reservoir in or near the tray andin close proximity to the patient or within the sterile field can bepreferable in some embodiments to, among other things, minimize thetubing length required, which improves the performance andresponsiveness of the aspiration system. This reduces the path length ofthe aspirated fluid, thereby reducing the requirements of the aspirationmechanism and eliminating long tubing sets that slow the response time(for example, when the surgeon changes the rate of aspiration orswitches from aspiration to reflux) and can entangle the surgeon andassistants in the operating room.

The tray may in some embodiments comprise stopcocks or other valves(manual or automated) to select between different aspiration intakesources (for example, a vitreous cutter handpiece and a soft tripextrusion handpiece).

Handpieces

In some embodiments, the tray system may comprise one or more handheldprobes or handpieces that may comprise a needle (for example, 18 gauge,20 gauge, 23 gauge, 25 gauge, 27 gauge or other size) inserted intoeither the anterior or posterior chamber of the eye during a surgicalprocedure (such as, for example, one or more of the various handpiecesdescribed herein with reference to FIGS. 1E, 4A, 5A, 6A, and 8A).Handpieces in some embodiments may comprise one or more of vitreouscutters/aspirators, endoilluminators, laser therapy/photocoagulationprobes, diathermy/electrocautery/ablation probes, scissors, soft-tipextrusion probes, phacoemulsification/phacomorcellation probes,intraocular lens (IOL) inserters, forceps, mechanical probes, and/orother commonly used instruments. Some handpieces may incorporate morethan one function. A handpiece may in some embodiments comprise one ormore buttons and/or other user interfacing features that allow thesurgeon to control the functions of that specific handpiece and/orpossibly other functions as well (such as, for example, rates ofinfusion or aspiration).

Vitreous Cutter Handpiece

In some embodiments, a tray system comprises a vitreous cutter handpiecefor removal of vitreous during a vitreoretinal procedure. The handpiecemay in some embodiments be tethered to the tray via a multi-conductorcable that provides power and an optional communications interface (forexample to communicate with the tray or base unit electronics, forexample the status of button presses on the handpiece). In someembodiments, the cutter mechanism may be powered by a motor or motor andgear assembly inside the handpiece. In some embodiments, the cuttermechanism may be powered pneumatically by an external pneumatic source(for example, a pump, compressor, compressed gas source, and/or thelike) that is connected to the handpiece via one or more flexiblepneumatic tubes. The external pneumatic source may be located within thetray or the non-disposable base unit (for embodiments that incorporate abase as previously described). The cutter mechanism may in someembodiments be powered by a transmission cable or torque coil thatrotates, reciprocates, or translates in one or more axes. Using theprinciples of electromagnetism, the cable or coil may be used to supplyelectrical power to the handpiece as well, for example by rotating orotherwise moving a magnet in proximity to a wire coil and generating acurrent that can power the electronics of the handpiece. The cable orcoil may be driven by a motor, solenoid, electromagnet, linear actuator,and/or the like that is located external to the handpiece, for examplein the tray or non-disposable base unit. The cable or coil connected tothe handpiece may be coupled to the motor or drive actuator in the basevia a shaft coupling, spline coupling, or similar to enableease-of-setup by a surgeon or assistant in the operating room. In someembodiments, a magnetic coupling may be used to maintain a sterile fieldbetween the motor and the cable or coil. The cut speed, rate ofaspiration and other functions may be controlled by buttons or otheruser interfaces on the handpiece itself, or through a footpedal.

Similar drive configurations may also be used for lens removal orphacomorcellation handpieces as well as other mechanically-driveninstruments.

In some embodiments, a vitreous cutter handpiece may be a handpiece 810as illustrated in FIGS. 8A and 8B, as further described below. In someembodiments, a vitreous cutter handpiece may comprise one or morefeatures similar to as disclosed in U.S. Patent Application PublicationNo. 2008/0208233, entitled DISPOSABLE VITRECTOMY HANDPIECE, which ishereby incorporated by reference herein in its entirety.

Endoilluminator Handpiece

In some embodiments, a tray system may comprise an endoilluminatorhandpiece that provides illumination inside the eye. The handpiece maybe tethered to the tray in some embodiments via a multi-conductor cablethat provides power and an optional communications interface (forexample to communicate with the tray or base unit electronics, forexample the status of button presses on the handpiece). Theendoilluminator may in some embodiments incorporate a light source (forexample, white LED or RGB LED) that is coupled to a fiber or fiberbundle installed in an endoscopic needle. Alternately, the light sourcemay be located in the tray or base unit and coupled (either permanentlyor using a detachable interface) to a fiber or fiber bundle thatterminates in an endoscopic needle in the handpiece.

In some embodiments, an endoillumination handpiece may comprise one ormore features similar to as disclosed in U.S. Pat. No. 8,172,834,entitled PORTABLE HANDHELD ILLUMINATION SYSTEM, which is herebyIncorporated by reference herein in its entirety.

Soft-Tip Extrusion Handpiece

The tray system may in some embodiments comprise a soft-tip extrusionhandpiece that incorporates a soft tubing material (for example,silicone or the like) for aspirating vitreous and fluids from theretina. The handpiece may in some embodiments be tethered to the trayvia a multi-conductor cable that provides power and an optionalcommunications interface (for example, to communicate with the tray orbase unit electronics, for example the status of button presses on thehandpiece). The rate of aspiration and other functions may be controlledby buttons or other user interface features on the handpiece itself, orthrough a footpedal. The endoillumination power output and otherfunctions (such as infusion rate) may in some embodiments be controlledby buttons or other user interface features on the handpiece itself, orthrough a footpedal.

Diathermy/Electrocautery Handpiece

The tray system in some embodiments may comprise a bipolarelectrocautery handpiece that is capable of controlled cauterization oftissues. The handpiece in some embodiments may comprise two nestedneedles or tubes separated by an insulating layer (such as, for example,polyimide tubing or the like). The exposed distal end of the two needlesor tubes act as electrodes for the bipolar electrocautery. The handpiecemay in some embodiments be tethered to the tray via a multi-conductorcable that provides power and an optional communications interface (forexample to communicate with the tray or base unit electronics, forexample the status of button presses on the handpiece). The handpiecemay in some embodiments have integrated electronics for generating thehigh voltage waveform required for electrocautery, or alternately theelectrocautery circuitry may be located in the tray or base unit andsupplied to the handpiece via insulated wires. Thediathermy/electrocautery function and other functions may be controlledby buttons or other user interface features on the handpiece itself,and/or through a footpedal.

Laser Therapy Handpiece

The tray system in some embodiments may comprise a fiber-based laserhandpiece that is capable of photocoagulation. The handpiece may in someembodiments be tethered to the tray via a multi-conductor cable thatprovides power and an optional communications interface (for example tocommunicate button presses and system status with the tray electronics).The handpiece may in some embodiments incorporate a light source, suchas a laser diode, that has sufficient power for photocoagulation. Thelaser diode may in some embodiments be coupled to a fiber or fiberbundle that is mounted inside an endoscopic needle for insertion intothe eye or other surgical site. Alternately, the light source andassociated optics may in some embodiments be located in the tray or baseunit with either a permanent or interchangeable optical interface to afiber or fiber bundle that terminates in an endoscopic needle located inthe handpiece. The laser therapy power output and other functions may becontrolled in some embodiments by buttons or other user interfacefeatures on the handpiece itself, or through a footpedal.

Scissors

The tray system in some embodiments may comprise a powered scissorshandpiece that enables the surgeon to cut tissue without requiringmanual manipulation, for example using fingers to squeeze, slide, orotherwise activate the cutting mechanism of the scissors. In oneembodiment, the scissors are tethered to the tray via a multi-conductorcable that provides power and an optional communications interface (forexample with the tray electronics). Power to the cutting mechanism isprovided in some embodiments by the tray via the tethered cable. Thecutting mechanism may in some embodiments comprise a motor, solenoid,linear actuator, nitinol or shape memory alloy wire (for example, a wirethat contracts when a current is passed through the wire and expandswhen the current ceases and the wire cools), and/or the like. Alternateembodiments may position the actuator in the tray or base, andmechanical cutting may be provided via a linkage, such as a transmissioncable or torque coil that is rotated, reciprocated, or translated alongone or more axes.

Handpiece Storage

In some embodiments, a tray may comprise space configured to hold thehandpiece(s) when they are not in use (such as, for example, the spaces111 illustrated in FIG. 1E), and/or may provide connectivity to thehandpiece(s) via one or more of an electrical, fluidic, pneumatic,optical, and/or mechanical interface. The spaces to hold the handpiecesand the top surface of the tray in general may in some embodimentscomprise features to cope with undesired fluids that may be present onthe tray during the procedure. For example, the tray top and handpieceareas (which may be recessed pockets or wells) may have recessedchannels or holes to drain any fluids or carry any fluids away.Likewise, any recessed areas may include absorbent or sponge-likematerials to absorb any unwanted fluids. The handpieces may be mountedin the tray prior to packaging and sterilization to simplify the pre-opsetup procedure. The tray may in some embodiments include clips, straps,or other locking mechanisms that enable the handpieces to be secured inplace, for example during shipment or movement of the tray. Additionalhandpieces may be packaged and sterilized separately, for example toenable replacement of a failed handpiece during a procedure withouthaving to open an entire new tray system.

Handpiece User Interface Features

Some embodiments of handpieces comprise one or more means of acquiringuser input, such as one or more buttons or switches (including, forexample, membrane, tactile, pushbutton, rotary, joystick, hall sensing,capacitive touch, pressure sensitive, and/or the like) located on thehandpiece, and/or inertial sensors (including gyro(s), accelerometer(s),magnetometer(s), and/or the like). These input methods can be used tocontrol one or more functions of the handpiece and/or console, such as,for example, activating, deactivating, and controlling the probe tipmotion and aspiration functions. For example, in some embodiments, thesurgeon may press and hold one button to activateemulsification/morcellation, and release the button to stopemulsification/morcellation. The surgeon may press and release anotherseparate button repeatedly to cycle through aspiration rates. Theinertial sensors can be used in some embodiments for position trackingas well as user input. For example, the surgeon may orient or move thehandpiece in a particular manner to perform a function; an example wouldbe deactivating the system when the handpiece is placed upside down on atray or table (the system would recognize the upside down orientation ofthe handpiece and the lack of motion/movement); a second example wouldbe lightly tapping on the handpiece with a finger to activate ordeactivate a function (the accelerometer will detect the handpiecedeflection caused by the tapping); yet another example would be rotatingthe handpiece in a clockwise fashion to increase the rate aspiration orsome other function and rotating the handpiece in a counter-clockwisefashion to decrease the rate of aspiration or some other function (wherethe angular motion is detected by the gyro). The user input may in someembodiments be processed or otherwise acted upon internally within thehandpiece, or the input may in some embodiments be relayed to a separateconsole or tray via a tethered electrical connection (for example,conductive wires/cables) or wireless connection (for example, RF,inductive, or infrared) for example. The handpiece may in someembodiments comprise a microcontroller or microprocessor for registeringuser input, controlling the functions of the handpiece, and/orcommunicating with external components of the system (for example aconsole or tray). The handpiece may in some embodiments comprisewireless capabilities to transmit and receive information to/from aseparate console, tray, display, and/or other handpieces.

Some embodiments comprise analog buttons (such as, for example, apressure or deflection sensitive button) that provide finer control overthe handpiece functions than a standard binary (on/off) or momentaryswitch. For example, one or more analog buttons sensitive to pressure ordeflection may be used to provide fine control of functions such as, forexample, cut speed, aspiration, or illumination/laser power output. Inone embodiment, one or more pressure-sensitive buttons in the grip ofthe handpiece can be used to control rate of aspiration or cut speed;the harder the surgeon squeezes, the higher the cut speed or rate ofaspiration for example. Likewise, other sensors can be incorporated thatmeasure flexion, deflection, or translation such that the further asurgeon pushes, slides, or otherwise moves a button, the higher the rateof, for example, aspiration or cut speed. This can be achieved, forexample, with button implementations that vary a parameter (such asresistance or capacitance) based on an applied input (such as pressureor deflection). For example, one button implementation may be sensitiveto pressure such that the harder the surgeon squeezes, the lower (orhigher) the resistance, which can be measured by the handpieceelectronics (and/or remote electronics, such as electronics located in atray or base). Another implementation utilizes a change in capacitance,such that the distance (and therefore capacitance) between two parallelconductive plates varies with the force applied to a button. Anotherimplementation may connect different circuits depending on how far abutton is depressed or moved. Yet another implementation may utilizemagnetic sensors to detect the location of a magnet and/or magneticfield strength to determine how far a button has been depressed ormoved. Yet another implementation utilizes capacitive touch technologyto provide analog control.

FIGS. 8A and 8B illustrate an embodiment of a handpiece or surgicalinstrument 810 comprising a housing or body 802 having a plurality ofbuttons 812, 808. FIG. 8A is a perspective view of the handpiece 810,and FIG. 8B is a perspective view of the handpiece 810 with the housingor body 802 removed to enable visualization of features positionedbeneath the housing 802. The handpiece 810 comprises a proximal end 806adjacent a cable interface 807, and a distal end 804 having a surgicaltool 805, such as a needle, extending therefrom. In some embodiments,the surgical tool 805 is permanently or semi-permanently installed. Insome embodiments, the distal end 804 is configured to enable a surgicaltool 805 to be positioned in a coupled engagement with the distal end804.

The handpiece 810 comprises three buttons 808 positioned adjacent to anexterior surface of the housing 802. In this embodiment, the buttons 808comprise digital, binary, or momentary buttons or switches, meaning theyhave two states, namely on or off, for controlling of a feature. Thebuttons 808 may, for example, comprise mechanical switches thatselectively open and close an electrical circuit when an actuationsurface of the button 808 is moved relative to the housing 802.

The handpiece 810 further comprises in this embodiment two pressuresensitive buttons 812. In other embodiments, the handpiece may comprisefewer or more pressure sensitive buttons. Each of the two pressuresensitive buttons 812 comprises a circumferential force-sensitiveresistor 813 that is configured to change a resistance value based on amagnitude of pressure applied against a surface of the force sensitiveresistor 813. In some embodiments, the force sensitive resistor 813comprises a thin multilayer polyimide sheet. In some embodiments, as canbe seen in FIG. 8A, the buttons 812 comprise an actuation surfaceextending circumferentially around the handpiece 810 and/or housing 802that, when depressed, presses against the force sensitive resistor 813.In some embodiments, the exterior surface of the buttons 812 comprisetactile regions or features 814, illustrated in FIG. 8A as a pluralityof raised bumps spaced circumferentially around the handpiece 810 and/orhousing 802. Such a configuration may be advantageous to, for example,enable a user or surgeon to precisely control a feature when thehandpiece 810 is in any rotational position with respect to the user'shand.

As used herein, the word “button” may be used interchangeably with otherwords or phrases, such as switch, selector, user input, and/or the like.One of skill in the art will recognize that a variety of user interfacefeatures, including buttons or other similar features, may be used withthe techniques disclosed herein to detect a user input.

In addition to traditional on/off or momentary buttons and analogbuttons that depend on some type of electrical or electromechanicalcontacts, additional user input solutions are feasible that eliminatethe need for electronics in the handpiece and/or the need for tetheredpower and communication interfaces to the handpiece. Such embodimentsmay be advantageous to, among other things, increase manufacturabilityand/or reduce cost of disposable components of the system, such as, insome embodiments, the handpieces.

Optical Buttons

In some embodiments, user input can be detected using buttons that relyon principles of optics and optical fiber, instead of (or in someembodiments, in addition to) electrical or electromechanical features.For example, in some embodiments, one or more buttons may have one ormore fibers, light pipes, or optical waveguides associated with it, thefibers extending from the handpiece to the tray or base unit electronics(either as a continuous fiber or one or more fiber sections opticallyconnected together). The fiber may be coupled to a light source (such asa light source located in the tray or base unit) and may propagate lightto the button location. A button may be designed to bend or otherwiseflex the fiber when the button is depressed, reducing or eliminating thelight propagation through the fiber and/or changing the polarization ofthe light through the fiber, both of which are detectable by theelectronics and can be used to indicate a button press. Otherembodiments instead alter or route/reroute the light path (e.g. areflective surface on a button, the surgeon's fingertip, etc.) such thatthe change can be detected and identified as a button press. Theprinciples of fiber interferometry can also be used, such that a buttonpress sufficiently alters the fiber so that the changes to phasealtering interference fringes and the location thereof can be detectedand interpreted as button presses. In a similar fashion, fiber Bragggrating sensors, long-period fiber grating sensors, and similarembodiments can be integrated into the fiber(s) to measure strain,thereby detecting changes in the fiber and their location(s). Someembodiments may utilize one of the optical techniques disclosed herein,and some embodiments may utilize more than one of the optical techniquesand/or may utilize one or more of the optical techniques and one or morenon-optical techniques.

In some embodiments, one or more buttons each have a single continuousfiber associated with it. The fiber is routed from the electronics inthe tray or base to the handpiece button and back to the tray or base(either as a continuous fiber or as two or more sections opticallycoupled together). When the button is pressed, the fiber is bent in sucha manner as to decrease or eliminate the light propagation, change thepolarization of the light in a detectable manner, or induce strain inthe fiber that alters the interference fringes in a detectable manner.In other embodiments, one or more buttons each have two fibersassociated with it (each either as a continuous fiber or as two or moresections optically coupled together), one that carries the light fromthe tray to the button and another that acts as a return for the lightback to the tray. The button is designed such that when it is depressed,light is allowed to propagate from the source fiber to the return fiber.This can be accomplished, for example, with a reflective surface or atransmissive or light pipe material that is angled or positionedproperly when depressed, or even using the surgeon's fingertip toredirect the light from the source fiber to the return fiber.

Another embodiment comprises a single fiber for both the source andreturn path of the light, since fiber can simultaneously propagate lightin both directions. For example, an optical circulator can be configuredto allow light to be injected into the fiber at the source (such as thetray or base unit) while simultaneously separating any reflected lightalong the same fiber to be detected by a photodetector or other sensorin the electronics. Such reflections could be caused by a reflectivesurface (or even fingertip) at the end of the fiber, or even a bend,flex, or twist of the fiber.

In another embodiment, a single fiber or optical waveguide provides thesource light to each button, and each button has an additionalindividual return fiber to indicate button presses.

In other embodiments, instead of individual fibers for each button, asingle fiber is routed from the tray or base to each button in seriesand back to the tray or base. Different buttons are designed to alterthe polarization or light propagation different amounts, such that eachbutton can be distinguished from each other. Alternately, the opticalpath distance (such as the fiber length) between each button can beadjusted such that the principles of optical time domain reflectometryor similar can be used to determine the location along the fiber of thebutton press, and hence which button was pressed.

FIGS. 9A-9D illustrate example embodiments of handheld medicalinstruments or handpieces comprising one or more optical buttons. FIG.9A illustrates schematically a handpiece comprising a housing orenclosure 802 having two optical fibers 906 passing therethrough. Inthis embodiment, an actuating member 904, when placed close to tips orends 907 of the optical fibers 906 is configured to reflect light fromone optical fiber 906 to another optical fiber 906, the reflection ofwhich may be detected by hardware, for example, in a surgical tray orconsole. In some embodiments, the actuating member 904 is a portion of aphysical button that is configured to reflect light. In someembodiments, the actuating member 904 is a user's finger, in someembodiments a gloved finger.

In some embodiments, the two separate optical fibers 906 may also beimplemented as, for example, a single fiber with two or more waveguides,for example the source light would propagate down the core and thereturn light down one or more claddings of the fiber, or vice versa.Also note that a single source fiber may in some embodiments supplylight to multiple buttons, with each button paired with an independentreturn fiber or independent waveguide, for example, multiple claddings,in a custom-designed return fiber. Alternatively, each button may have aseparate source fiber providing light modulated at a different frequencyfor each button, with a common shared return fiber, with the modulatedsignal allowing the processing hardware to distinguish between differentsignals.

In some embodiments, a technique for enabling multiple buttonsincorporates a filter or attenuator that attenuates the lightpropagation through each button differently (for example, 100%, 50%,25%, and/or the like) or filters the wavelength (assuming a broadbandlight source) through one or more or each button so that the remainingwavelengths or the power attenuation could be measured by the processinghardware, such as, for example, in the surgical tray or console. In someembodiments, the wavelength of the light may be broadband (for example,white light or multi-wavelength light) or it may be single wavelength(for example infrared) and may be modulated to minimize interferenceissues with other ambient sources of light.

FIG. 9B illustrates another embodiment of a surgical handpiececomprising an optical button. The embodiment illustrated in FIG. 9Bcomprises an optical fiber 906 terminating at an end or tip 907. Anactuating member 904 may have light reflective properties such that,when the actuating member 904 is positioned adjacent the tip 907, lightis reflected back into the fiber 906, which can then be detected by, forexample, tray or console hardware. Sensitivity in some embodiments canbe adjusted to require contact by the actuating member 904 with the tip907 and/or handpiece enclosure 802, or just a proximity to the tip 907and/or handpiece enclosure 802.

FIG. 9C depicts another embodiment of an optical button. The embodimentillustrated in FIG. 9C comprises two optical fibers 906 and an actuatingmember 904 which, when moved relative to the enclosure 802 and/or fibers906, moves a reflective member 908. When the reflective member 908 ispositioned in front of tips or ends 907 of the optical fibers 906, lightis reflected from one optical fiber 906 to the other optical fiber 906,enabling detection of the button press by processing hardware locatedat, for example, the surgical tray or console.

FIG. 9D depicts another embodiment of an optical button, wherein adeflectable member or portion 910 connected to or part of one or moreoptical fibers 906 is positioned to be deformed when an actuating member904 is moved relative to the handpiece enclosure 802. For example, whenthe actuating member 904 contacts and/or presses against the deflectablemember 910, the deflectable member 910 may bend or otherwise deformed ina manner that may be detectable by processing hardware, such asprocessing hardware located in or as a part of the surgical tray orconsole. In this embodiment, if the button is depressed, the actuatingmember 904 will bend the deflectable member 910. If the deflectablemember or portion 910 is deflected sufficiently, the propagation oflight through the fiber will be significantly decreased or eliminated,which can be detected by the processing hardware and interpreted as abutton press. In an alternate embodiment, more light instead of lesslight is allowed to propagate the harder or further the button ispressed.

In some embodiments, the optical button configuration illustrated inFIG. 9D can also be configured to provide linear or pressure sensitivefeedback through one or more of several techniques. First, the decreasein light throughput will correlate to how much deflection or bending thefiber is experiencing. The amount of light detected can be used todetermine the overall position of the button. So, for example, theharder or further the user pushes the button, the greater the measuredchange in light throughput. Similarly, the bending of the fiber willchange the polarization of the light through the fiber. This can also bedetected by processing hardware and used to determine the magnitude ofdeflection. More advanced optical theory can also be used. For example,the fiber button can be one arm of a fiber-based interferometer(michelson, common path, mach zehnder, and/or the like) such that thechange in optical path length and the phase changes induced in the fiberdue to stress or bending can be detected in the processing hardware andmeasured to determine how hard or far the button was depressed. Anothertechnique is to include gratings in the fiber during manufacturing toproduce a strain sensor, such as a Fiber Bragg Grating Sensor orlong-period fiber grating, that can be used to provide linear orpressure sensitive button functionality due to the correlated change inwavelength resulting from strain on the fiber (for example, caused bypressing or bending the fiber). These grating sensors can also be usedfor multiple buttons with only a single fiber by designing a gratingalong the fiber with different properties for each button such that theproperties of each grating are distinguishable from each other by theprocessing hardware.

Yet another embodiment can use a single fiber for multiple linear orpressure sensitive buttons by detecting where along the fiber a strainor bend was induced, and correlating this to the position of the one ormore buttons. This detection can be implemented using principles of timedomain reflectometry, wherein the time for a light pulse to propagatethrough the fiber and reflect back to the source is measured and thedistance determined, with the reflection caused by the button inducing astrain or impedance in the fiber. This is more difficult over a shorterfiber length and would benefit in some embodiments from the addition offiber between the buttons to increase an optical path length betweenbuttons.

In some embodiments, an optical button configuration may comprise one ormore optical waveguides in addition to or in lieu of one or more opticalfibers, such as a plastic light pipe or the like. Further, in variousembodiments disclosed herein that refer to optical fibers, it should beunderstood that those optical fibers may be a continuous optical fiberand/or may comprise one or more sections coupled together, and or maycomprise one or more optical waveguides in series with a fiber.

In some embodiments, an optical button is configured to enable, disable,or attenuate the propagation of light from a source waveguide (or fiber)to a return waveguide (or fiber), for example, with a reflective orabsorptive surface, including a finger, to enable detection of a buttonpress.

In some embodiments, an optical button uses a single fiber or waveguidein a loop configuration and alters a property of light in a detectablefashion, for example, by bending the fiber or waveguide. This propertycan be the power or magnitude (for example, attenuating or increasingthe light throughput), the polarization of the light, the wavelength ofthe light (for example, by filtering out some wavelengths of a broadbandlight source and detecting the remaining wavelengths; or by shifting orfiltering the wavelength for example through a grating design), theoptical path length or phase of the light (for example, by bending orstraining the fiber which can be detected in an interferometer setup). Arelated embodiment relies on the principles of total internal reflectionand “evanescent waves.” For example, by touching the outer surface ofthe fiber (stripped of any outer protective coating, if present), therefractive indices at the fiber interface are changed (for example,fiber to finger instead of fiber to air) which can alter the propagationof light through the fiber. This change may be detectable withsufficiently sensitive amplification and processing equipment.

In some embodiments, an optical button uses one fiber for multiplebuttons, for example by using custom fibers with multiple waveguides(and possibly modulating the signal to or from different buttons); byfiltering out different wavelengths depending on which button is pressed(for example, using multi-wavelength or broadband light); by attenuatingthe light by different amounts depending on which button is pressed; byusing different fiber grating parameters for each button; by measuringthe time for reflected pulses to propagate (time domain reflectometry)where the reflection is caused by a deformation or strain in the fibercaused by the activation of a button.

Pneumatic/Hydraulic Buttons

In some embodiments, buttons that utilize pneumatic and/or hydraulicprinciples are incorporated into the handpiece, which can in someembodiments (similarly to as with the optical button embodiments)eliminate the need for any electronics or electrical interfacing betweenthe handpiece and the tray or base unit.

In some embodiments, one or more buttons of the handpiece may beattached to or fluidly coupled with a flexible pneumatic tube (forexample, flexible silicone, vinyl or PVC tubing or the like) that isconnected to the tray or base unit electronics (either using acontinuous section of tubing or two or more sections in fluidcommunication). The electronics may comprise, for example, a pressuresensor that can measure the pressure inside the tube. This can be usedto determine whether or not a button is pressed. For example, adepressed button may seal or pinch the tube that is otherwise open,unobstructed, or patent, in such a way that is detectable by thepressure sensor. Similarly, in some embodiments, the tubing mayterminate in the handpiece such that the surgeon may cover the hole inthe end of the tubing (such as with his or her finger) to indicate abutton press. A bladder or balloon, for example at the end of thetubing, may be included such that when the bladder or balloon isdepressed or otherwise modified (such as by an external force, forexample, from a finger or from a movable component of the handpiece),the change in internal air/fluid pressure can be detected andinterpreted as a button press. In some embodiments, instead of relyingon ambient pressure, the tubing may be fluidly connected to an air orvacuum source such that the measured pressure will be differentdepending on whether or not the tubing is patent or sealed. In thisembodiment, each button would have its own independent tubing. Inanother embodiment, multiple buttons can share a single tube, forexample if each button restricted the flow through the tube to adifferent magnitude, such that each button would be distinguishable fromthe rest. For example, the first button may restrict the tubingcompletely, while the second button restricts the inner lumen of thetubing 75%, the third button 50%, the fourth button 25%, and so on,which may be distinguishable by a fluidly-coupled sensor.

FIGS. 10A-10C illustrate example embodiments of handpieces comprisingpneumatic or hydraulic buttons. FIG. 10A illustrates schematically anexample wherein an actuating member 904, such as a finger or a portionof a button, deforms a deformable member 1002 fluidly connected withtubing 1004 to enable detection of a change in pressure in thedeformable member 1002 and/or the tubing 1004. In some embodiments, aflexible tube (e.g. vinyl or silicone tubing) 1004 with a balloon orbladder 1002 attached to the end of the tube that has some gas or fluidwithin it (e.g. air) can be used as a linear button. The harder theballoon or bladder 1002 is squeezed, pushed, or compressed, the higherthe pressure inside the tube, which can be measured and processed by apressure sensor and processing electronics located, for example, in theremote console or tray.

In some embodiments, the balloon or bladder 1002 may be directly pressedby the user's finger, or a button, lever, or other feature activated bythe user's finger(s) or grip may apply the force to the balloon orbladder.

In some embodiments, the balloon or bladder 1002 does not have to be aseparate component but can be integrated into the tubing 1004 itself.The tubing 1004 can be designed to have a ballooned area (for example, asegment with a larger diameter). A similar result can also be achieved(for example, the change in pressure can be detected and interpreted asa button press) by squeezing or compressing a tube that is simply sealedon the end. The advantage of a balloon or bladder with a larger diameterthan the rest of the tubing is that the squeeze or compressive forcewill be amplified and therefore easier to measure by the pressure sensorand processing electronics and less susceptible to noise orinterference.

In some embodiments, multiple buttons can be included in the handpieceby repeating the design of FIG. 10A; however it is also possible toincorporate multiple buttons using a single flexible tube with multipleballoons or bladders. Each balloon or bladder could, for example, in oneembodiment, have a different diameter/volume, such that when pressed theprocessing hardware could determine which button was pressed (forexample, which balloon was compressed) based on the amplitude of thesignal. This permutation may be desirable to use with, for example,on/off or momentary buttons as opposed to linear buttons, although itcould also be used with pressure-sensitive or linear buttons.

FIG. 10B illustrates another embodiment of a pneumatic or hydraulicbutton wherein a flexible tube 1004 (for example, vinyl or siliconetubing) that is open (for example unsealed) on the button end 1006 canbe used to detect button presses. If the user presses their finger (oran another actuating surface) on the open end 1006 of the tube 1004, apressure sensor and sensitive electronics that amplify and process thepressure signal can detect the changes in pressure and register a buttonpress (for example, momentary or on/oft).

FIG. 10C illustrates another embodiment of a pneumatic or hydraulicbutton wherein a flexible tube 1004 (for example, vinyl or silicone) canprovide pressure sensitive, linear, or digital (for example, on/off ormomentary) functionality. The tube 1004 is routed from the console ortray to the handpiece and back to the console or tray. There is an airsource pumping air into one end of the tube and a pressure or flowsensor on the other end of the tube. When the user's finger (or anotheractuation surface) 904 presses against the tube (or against a button,lever, or similar, for example comprising opposing members 1008, 1010)the tube is constricted. The more the user squeezes, the more the tubeis constricted, potentially to the point that no air can flow.Alternately, instead of squeezing the tube, the tube may be bent, whichwould likewise cause a reduction in air flow due to the collapsing wallof the pliable tubing. This change in air flow can be detected by thesensor and correlated to the amount of compression or deflection of thetube, thereby providing a linear style button output.

Embodiments of this and other designs can even use the pneumatic sourcethat is often used to drive certain instruments such as aspirators andvitreous cutters.

Piezo Buttons

In some embodiments, buttons comprising piezo material (for examplepiezoelectric quartz or the like) provide user input functionality.Piezo crystals when bent, flexed, or otherwise deflected generate avoltage spike that can be used as an input mechanism. For example, amechanical button designed to deflect a piezo material will generate avoltage when the button is pressed. If the piezo material is coupled viaelectrical wires to electronics in the tray or base unit (or in someembodiments in the handpiece), this voltage spike can be detected andinterpreted as a button press. While the handpiece is tethered to thetray or base unit electronics with electrical wires in this embodiment,there are no active electronics required in the handpiece itself in thisembodiment and it is not necessary to supply power to the handpiece viaany wires or cables. Multiple buttons can be incorporated into thehandpiece, each completing a separate circuit (for example, twoindependent wires per button or one independent wire and one sharedground wire); alternately, multiple buttons can share a single circuitor pair of wires to the tray or base unit by designing each piezoelement to generate a different range of voltages such that each piezoelement is distinguishable from the others based on the magnitude of thevoltage generated when the button is pressed.

FIG. 11 illustrates an embodiment of a handpiece having a piezoelectricbutton comprising electrical wires 1102 coupled to piezoelectricmaterial, such as a piezo crystal 1104 to detect deformation of thecrystal via a voltage differential measured across the wires 1102. Insome embodiments, the crystal 1104 is configured to be deformed by oneor more of the actuating members 904, 904′.

In some embodiments, the piezo button incorporates one or more piezocrystals or elements that are connected electrically to the tray orconsole. No power is applied to the piezo crystal through the wires:instead the piezo element will produce a voltage when it is bent ordeflected which can be detected by the tray or console electronics. Theamplitude of the voltage that is generated is proportional to the amountof deflection of the piezo element—so the further the piezo isdeflected, the higher the voltage spike. This property can be used toprovide a pressure sensitive or linear-style output.

To incorporate multiple buttons without simply repeating the design foreach button, multiple piezo elements can in some embodiments share asingle set of wires if, for example, each piezo element is designed toprovide a different voltage at a given deflection, such that thedifferent voltage ranges are distinguishable from each other and can becorrelated to a particular button. Alternately, each button can bedesigned to deflect its respective piezo element (assuming all piezoelements have approximately the same specifications) a different amount,thereby producing a different voltage amplitude range depending on whichbutton is pressed.

In any of the illustrative embodiments disclosed in FIGS. 9A-11, thebuttons can be binary on/off switches, or variable switches that produceresponses or outputs that are linear, non-linear, or a combination oflinear and non-linear with respect to the input received by the button.

Power Sources

Embodiments disclosed herein may employ one or more of a variety ofpower sources to perform the intended functions, including but notlimited to actuation of the probe tip and aspiration as well asreceiving and/or processing user input. The handpiece may in someembodiments be tethered to a console or tray that provides power (forexample DC or AC voltage or current) via electrical wires. The handpiecemay in some embodiments be powered by a rechargeable (secondary)internal battery (such as lithium ion/lithium polymer, NiMH. NiCd, orother chemistry), a non-rechargeable (primary) internal battery (such asalkaline, lithium manganese, or other chemistry), and/or an internalcapacitor of sufficient capacity (such as a “super-capacitor” or“ultra-capacitor”). The handpiece can be in some embodiments poweredwirelessly via a wireless power coupling system. For example, thehandpiece may incorporate a “secondary” coil that can be inductivelypowered from a “primary” coil that is strategically located in proximityto the handpiece and driven by a power amplifier. For example, theprimary coil can be mounted on the microscope and used to power ahandpiece containing a secondary coil and positioned by the surgeonunderneath the microscope during the surgical procedure. This inductivelink (or a different inductive link) can also in some embodiments beused for bi-directional communication between the handpiece and the trayor console. The handpiece may also in some embodiments be poweredpneumatically or hydraulically (tethered with tubing set to console ortray, for example) to provide emulsification and aspiration. Thehandpiece may in some embodiments be powered by a moving, reciprocating,or rotating cable transmission or torque transmission coil. Thehandpiece may in some embodiments be powered via a wound-up spring. Thehandpiece may in some embodiment comprise a turbine or other means ofconverting the cable, pneumatic or hydraulic power to electricity forpowering, for example, internal microcontroller(s), sensor(s),actuator(s), and/or button(s). The handpiece may in some embodiments bepowered by converting a squeezing, gripping, rotating, or sliding motionmade by the surgeon on the handpiece grip into a useful motion (forexample reciprocating or rotary motion to activate the probe tip). Thehandpiece may in some embodiments be powered by compressed air, forexample a canister or cartridge inserted into the handpiece, or anexternal source. Additional power sources may be used to provide thedesired functionality, and in some embodiments more than one powersource may be used to power a handpiece (for example, an AC voltagedriving a piezoelectric crystal mounted in a phaco handpiece forphacoemulsification and pneumatic power to provide the aspiration of thephaco handpiece).

Pressure-Sensitive Handpiece Tip

Some embodiments incorporate a pressure sensor in a distal tip of thehandpiece to provide intra-ocular pressure readings from the anteriorchamber or posterior chamber. The pressure sensor readings (and/orinformation derived from the pressure sensor readings) can be visuallydisplayed (for example, on a stand-alone display, heads-up display,in-microscope display, or a display integrated into the tray or console)and/or audibly announced. In some embodiments, alarms and/or safetymeasures may be activated based on the pressure sensor readings.Furthermore the pressure sensor readings may be used in some embodimentsin a feedback control loop to control the rate of infusion and/oraspiration during anterior segment or posterior segment procedures. Thepressure sensor may in some embodiments be of the MEMS variety. Thepressure sensor may in some embodiments be a fiber-based design. In someembodiments, the pressure sensor is incorporated into a separatecomponent (for example, instead of distal tip of the handpiece) that isalso inserted into or located adjacent to the anterior chamber orposterior chamber of the eye. For example, the pressure sensor may beincorporated into an infusion cannula or chandelier light source and thepressure measurements used to control the rate of infusion. Otherembodiments may be configured to rely on external IOP measurements takenthrough established measurement techniques and processed by thehandpiece or tray electronics.

Illumination

In some embodiments, the tray may comprise one or more light sources forproviding illumination at the surgical site. Endoscope-basedilluminators (endoilluminators) and other illumination devices, such aschandelier illuminators, can be coupled to the light source(s) via asingle fiber or bundle of multiple fibers. The fiber(s) may in someembodiments have large numerical apertures to maximize couplingefficiency. The fiber(s) may in some embodiments be butt-coupled to theLED source or interfaced through a lensing system. The endoilluminatorand chandelier illuminator, and/or the like can be permanently coupledto the light source via the fiber(s) or they may be coupled via anoptical connector configuration that efficiently couples light from thelight source into the fiber and allows the fiber of the handpiece to beattached and detached from the light source at will or on demand by thesurgeon. The tray may in some embodiments comprise high brightnessphosphor-based white LED(s) and/or RGB LED(s). More than one source maybe provided to simultaneously accommodate, for example, one handpieceendoilluminator and one chandelier illumination device through anoptical coupling; alternately, a single light source can be shared amongtwo or more illumination components, for example through a free-space orfiber splitter. The constituent colors of the RGB LED(s) may in someembodiments be adjusted individually to provide improved visualizationunder different conditions, for example in the presence of a dye, stain,or indicator. Other embodiments comprise a xenon, mercury vapor,halogen, and/or other light source located in the tray and opticalcoupled to the handpiece via fiber. Alternate embodiments include alight source (for example, LED or laser) in the handpiece itself; thelight source may be coupled (butt-coupled or otherwise) to a needlecontaining a light pipe, fiber, or fiber bundle that propagates thelight to the distal tip of the endoilluminator probe. The fiber or fiberbundle may in some embodiments have a large numerical aperture tomaximize coupling efficiency between the LED and the fiber. Alternately,the LED may be located at the distal tip of the needle, preferablysealed from the external environment (for example, behind a transparentwindow at the distal lip of the needle or potted in epoxy).

Laser Therapy

In some embodiments, the tray may comprise one or more laser sources forproviding photocoagulation, ablation, cutting, and/or other lasertherapy at the surgical site. For example, a laser therapy probehandpiece may comprise a fiber or fiber bundle mounted in an endoscopicneedle inserted into the eye. The fiber probe may be configured to focusor collimate the therapeutic laser for use during surgery. The lasertherapy probe can in some embodiments be permanently coupled to thelight source via the fiber(s) or they may in some embodiments be coupledvia a removable optical connector that couples light from the lightsource into the fiber. Alternate embodiments include a laser source inthe handpiece itself; the laser source may be coupled (butt-coupled orotherwise) to a needle containing a light pipe, fiber, or fiber bundlethat propagates the light to the distal tip of the laser therapy probe.

Display

In some embodiments, the tray may comprise one or more display(s) (forexample, indicator(s), interface(s), LCD(s), and/or LED(s)) fordisplaying system information. The tray may also include audio feedback.The display(s) may also be located separate from the tray. Display(s)may be mounted in a heads-up configuration (for example, on themicroscope) or projected into the optical path of the microscope fordisplay within the visual field of the microscope. Display(s) may insome embodiments be located on or above the tray in the left and/orright periphery of the surgeon to enable viewing without turning thehead. Display(s) may in some embodiments be located on the tray directlyin front of the surgeon and viewable when looking downwards and providedwith a shade or cover that prevents light pollution from the displayfrom entering the microscope's objective lens or affecting the surgeon'svision. Alternately the display(s) may have a film, window, or othertransparent cover that is polarized or contains lenticular grooves,parallax barriers, or other features that enable viewing from limitedperspectives or are transparent from only a certain angle to preventlight pollution.

Audio Feedback

In some embodiments, the tray may comprise audio capabilities to providefeedback to the surgeon. The audio feedback may comprise in someembodiments a variety of tones with different frequencies, amplitudes,durations, and/or the like. The audio feedback may in some embodimentscomprise voice prompts that are capable of providing more useful andthorough feedback information to the surgeon. The voice prompts may bedigitized audio recordings/samples or synthesized speech, and the voiceprompts may be stored in non-volatile memory (for example, flash memoryor a hard drive). The tray electronics may in some embodiments comprisea microcontroller or microprocessor that controls the voice prompts(and/or tones, and/or other audio feedback), activating the proper audiofeedback based on input from the surgeon, a handpiece's hardware orsoftware, the tray's hardware/software, and/or the like.

Foot Pedal

In some embodiments, the tray may comprise or be connected to one ormore foot pedals (tethered or wireless) that enable control of thehandpiece and/or tray functions (including, for example, infusion andaspiration rates, cutter speed, illumination power, and/or the like).

Storage

In some embodiments, the tray may comprise one or more areas (forexample, holes, cavities, containers, voids, pockets, hooks, fasteners,magnets, and/or the like) configured to hold, store, or secure itemsused during the surgical procedure, including, for example, thehandpieces, sutures, syringes/needles, trocars, and/or other instrumentsor supplies. The tray may also in some embodiments comprise anintegrated sharps container to safely secure or dispose of sharps. Thetray may in some embodiments comprise a magnet or magnetic surface tohold needles, sharps, and other metal items/instruments in place.

Example Disposable Tray Embodiments

In one preferred embodiment, a tray system comprises a disposable traythat comprises disposable electronics and disposable pumps (for infusionand/or aspiration). The tray system also comprises disposable handpieceswith electronics and functional components integrated into one or moreof the handpieces (for example, motor for vitreous cutter, LED forillumination, and/or the like). In some embodiments, the entire traysystem is intended to be disposed of after a single use or limitednumber of uses.

In a second preferred embodiment, a tray system comprises a disposabletray with disposable pumps but with little or no active electronics. Theelectronics are integrated into a reusable base that interfaces with thedisposable tray and handpieces. The handpieces may comprise integratedelectronics and functional components.

In a third preferred embodiment, the tray itself comprises onlydisposable fluidic components. The reusable base unit incorporates theelectronics and pump drivers (for example, motors) while the disposablepump heads or a portion thereof are located in the disposable tray. Thehandpieces may include integrated electronics and functional components.

In a related preferred embodiment, the tray itself comprises onlydisposable fluidic components. The reusable base unit incorporates theelectronics and pump drivers (for example, motors) while the disposablepump heads or a portion thereof are located in the disposable tray.Other functional components are also incorporated into the base insteadof the handpieces. These include: a mechanical source for the cutter andsimilar instruments, which may be a pneumatic or hydraulic source or amotor source to drive a transmission cable or torque coil; a lightsource for endoillumination; a laser source for photocoagulation. Insome cases, the handpieces have no integrated electronics and rely onfiber-based, pneumatic, piezo, or similar non-electronic methods ofacquiring user input. Alternately the handpieces may not incorporate anybuttons and all control is done via a footpedal or buttons on the trayor reusable base unit.

Aseptic Container Modular or Hybrid Tray Embodiments

Some embodiments of surgical tray systems disclosed herein comprise amodular or hybrid design (as further discussed above), wherein one ormore disposable portions couples with one or more reusable portions tocreate the complete surgical tray system. In some embodiments, thedisposable portion is sterile and comprises (or otherwise provides foror creates) an aseptic cavity or enclosure configured to isolate areusable portion from the sterile surgical field. In some embodiments,the aseptic cavity completely encapsulates the reusable portion. Inother embodiments, the aseptic cavity covers at least enough of thereusable portion to isolate the reusable portion from the sterilesurgical field, but does not completely encapsulate the reusableportion. For example, the cavity may be configured to cover a top andsides of the reusable portion, but to leave uncovered a bottom of thereusable portion, with the bottom intended to be positioned out of thesterile surgical field and thus not requiring covering, even though thereusable portion is placed in close proximity to the sterile surgicalfield.

In some embodiments, a sterile disposable tray (or one or morecomponents of the tray) is configured to be opened up by the surgeon ina hinged, clamshell, or other fashion to enable a reusable module to beinstalled inside or underneath by the assistant (see, for example. FIGS.12A-12C, further described below). The hinged lid or clamshell wouldthen be closed, fully encasing or otherwise covering or isolating thereusable module and maintaining a sterile barrier between the reusablemodule (that may not be considered to be sterile) and the patient andsurgeon. In another embodiment, instead of opening in a clamshellfashion, the disposable tray or a portion of it contains a drawer, lid,door, window, or similar feature that can be opened to allow thereusable module to be inserted (see, for example, FIGS. 13A-13C, furtherdescribed below). In another embodiment, the reusable module is insertedinto or mounted to the underside of the sterile disposable tray (or acomponent thereof), which may provide a cavity, pocket, recess or othermounting feature to hold or secure the reusable module (see, forexample. FIGS. 14A-14C, further described below). In such an embodiment,a cover or lid may not be necessary because the manner and position inwhich the disposable tray is mounted to the surgical site (for example,the patient's bed or chair or the surgeon's armrest) may provide theproper boundary between the sterile and unsterile regions.

FIGS. 12A-12C illustrate an embodiment of a hinged or clamshell stylesurgical tray or apparatus 1210 comprising an aseptic container orcavity 1260 for insertion there in of a nonsterile reusable component1204. Electrical, mechanical, optical, and/or fluidic connections areconfigured to be made between the reusable 1204 and single-use 1202portions when the reusable portion 1204 is inserted into the single useportion 1202. Note that these drawings are only an example of such anembodiment. The actual single-use component 1202 can in some embodimentsbe smaller with some portions made to be reusable and simply draped orotherwise covered to provide a sterile barrier during a surgicalprocedure.

FIG. 12A is an exploded view of the surgical tray 1210, which comprisesa disposable portion 1202 and a reusable portion 1204. In someembodiments, the disposable portion 1202 further comprises a fluidreservoir 1223 and/or a BSS bottle holder or infusion assembly 1222. Insome embodiments, the BSS bottle holder 1222 and/or the fluid reservoir1223 may be modular in nature, enabling them to be removed from and/orinserted within the disposable portion 1202, similarly to as describedabove with reference to other embodiments. In some embodiments, the BSSbottle and/or reservoir features may be integrated into the disposableportion 1202 and not be removable or interchangeable. FIG. 12Billustrates the surgical tray 1210 after the reusable portion 1204 hasbeen inserted into the cavity 1260, but before the lid 1203 has beenclosed. FIG. 12C illustrates the surgical tray 1210 after the lid 1203has been closed.

With further reference to FIGS. 12A-12C, this embodiment of a surgicaltray or apparatus 1210 comprises a base portion 1205 and a lid 1203hingedly connected to the base 1205 via hinged sections 1207. In thisembodiment, the lid 1203 comprises areas for holding handheld medicalinstruments 110. In other embodiments, the lid may be smaller or largerthan as illustrated in this embodiment, positioned elsewhere, and/or maynot comprise areas for holding the instruments 110.

The reusable portion 1204 of the embodiment of FIGS. 12A-12C comprisesone or more electronic displays 118 configured to be viewable throughthe disposable portion 1202 when the reusable portion 1204 is positionedwithin the aseptic cavity 1260 of the disposable portion 1202. Further,the reusable portion 1204 may in some embodiments comprise one or moreother functional components configured to interface with the disposableportion 1202. For example, the reusable portion 1204 may comprise acomputer processor configured to control one or more functions of thesurgical tray, an optical light source, a laser source, a fluid sourceand/or reservoir, a motor, and/or the like. In some embodiments, the lid1203 and reusable portion 1204 may comprise electrical connectorssimilar to as illustrated in FIG. 4C.

FIGS. 13A-13C illustrate another embodiment of a surgical tray orapparatus 1310 comprising a sterile disposable portion 1302 and areusable portion 1304. The embodiment illustrated in FIGS. 13A-13C issimilar to the embodiment illustrated in FIGS. 12A-12C. The surgicaltray 1310, however, utilizes a drawer 1361 to access an aseptic cavityfor placement therein of the reusable portion 1304, instead of utilizinga hinged or clamshell style design. Note that FIGS. 13A-13C are only anexample of such an embodiment. In other embodiments, an opening forinsertion of a reusable portion can be designed as a door or lid,instead of a drawer, that is opened to install the reusable module. Aswith other embodiments, electrical, mechanical, optical, and/or fluidicconnections can be made between the reusable 1304 and single-use 1302portions when the reusable portion 1304 is inserted into the single useportion 1302.

FIGS. 14A-14C illustrate another embodiment of a surgical tray orapparatus 1410 comprising a hollow shell forming at least part of anaseptic cavity or container 1460 for insertion therein of a reusableportion 1404. The surgical tray 1410 is similar to the surgical trays1210 and 1310 described above. Surgical tray 1410, however, enablesaccess to the cavity 1460 by detaching or removing a top portion or lid1403 from a base or bottom portion 1405. In some embodiments, the baseor bottom portion 1405 can be configured to be reusable and/ornon-sterile, in which case the base or bottom portion 1405 may bedraped. In some embodiments, the top portion 1403 and bottom portion1405 together comprise a disposable portion 1402 of the surgical tray1410. In some embodiments, more or less components may comprise thedisposable portion 1402. For example, the disposable portion 1402 mayfurther comprise the infusion and/or reservoir modules 1222, 1223. Insome embodiments, the disposable portion 1402 comprises the lid or topportion 1403, but not the base 1405. Note that the embodiment shown inFIGS. 14A-14C is only an example of such a hollow shell embodiment. Inthis embodiment, the top tray 1403 is a shell, with the reusable module1404 placed in the underside. When the top tray 1403 is mounted to thebase portion 1405, mounting bracket, bed/chair, and/or armrest, thenon-sterile reusable portion 1404 is effectively isolated from thepatient and surgeon to provide a sterile barrier. Electrical,mechanical, optical, and/or fluidic connections are configured to bemade between the reusable 1402 and single-use 1404 portions when thereusable portion 1404 is inserted into the single use portion 1402. Inthis embodiment, the bottom 1405 may be reusable (in some embodimentsproviding either only structural support or possibly includingfunctional elements including but not limited to one or more powersupplies, batteries, light sources, pumps, compressors, and/or the like)or it may be a separate disposable item. The bottom 1405 may be drapedwith a standard drape or a custom drape to provide a sterile barrier,particularly if it is a reusable component and sterility cannot beensured for each surgical procedure. In various embodiments, thefunctionality may all be integrated into a single reusable functionalmodule or it may be separated into multiple functional modules.

Additional Modular Surgical Tray Embodiments

FIG. 15 illustrates another embodiment of a modular surgical tray orapparatus 1510. The surgical tray 1510 comprises a disposable portion1502 and a reusable base portion 1504. The surgical tray 1510 furthercomprises aspiration and infusion modules 1223, 1222. FIG. 15illustrates another example of having one or more disposable componentsthat are separate from reusable aspects of the system. The reusableportions (in this embodiment, the base 1504, which comprises displays118) may be draped with a sterile drape or they may be otherwise coveredto maintain a sterile barrier, for example by a thin vacuum formed ormolded plastic shell that may be integrated with some or all of thedisposable portions 1502, 1222, 1223 or provided as a separatecomponent. In some embodiments, disposable portion 1502 may be used torefer to just the handpieces unit, as shown in FIG. 15. In someembodiments, however, all disposable components or modules of thesurgical tray 1510 may be collectively referred to as the disposableportion (for example, the unit 1502, the infusion module 1222, and theaspiration module 1223).

FIGS. 16A and 16B illustrate another embodiment of a modular surgicaltray or apparatus 1610. This embodiment is similar to the tray 1510illustrated in FIG. 15. In FIGS. 16A and 16B, however, the disposablehandpieces unit 1602 is divided into three separate components: acentral module 1670, and two outer trays 1671. Each disposable componentof the surgical tray 1610 (for example, central module 1670, outer trays1671, aspiration module 1223, and/or infusion module 1222) is configuredto mate or couple with a different receiving or coupling feature 1672 ofthe reusable portion 1604. The base 1604 may be draped or otherwisecovered with a sterile barrier if desired. In some embodiments, alldisposable functional components may be primarily contained in a singlefunctional module, but in other embodiments, such as shown in FIGS. 16Aand 16B, the functional components may be distributed across multiplemodules.

Aseptic BSS Bottle Holder

Some embodiments of surgical systems disclosed herein comprise anaseptic transfer enclosure as applied to a BSS bottle or other infusionsource that is utilized in many surgeries. One example is shown in FIGS.17A-17C, where a non-sterile BSS bottle 1704 is enclosed within asterile BSS holder 1700 with a bottle spike 1708 located within thesterile work area. Such an embodiment allows a non-sterile BSS bottle tobe brought into the sterile field, which may provide superiorperformance over current solutions, because of the reduced length offluidic tubing between the infusion source (BSS bottle) and surgicalsite.

FIG. 17A illustrates the assembled BSS bottle holder 1700. FIG. 17Billustrates an exploded view of the BSS bottle holder 1700, comprising atop or cover 1702, a BSS bottle 1704, and a base or bottom 1706. In thisembodiment, the cover 1702 comprises a mechanic twist lock feature toattach the cover 1702 to the base 1706. In other embodiments, however,various other locking or coupling mechanisms may be used. FIG. 17Cillustrates more details of the base 1706, including inlet and outlettubing 1712, a spike 1708 for piercing the BSS bottle 1704, and anoptional tube 1710 for forced gas infusion. In some embodiments, thetube 1710 may comprise a tube that extends within the BSS bottle to anarea above the fluid level of the BSS bottle. The tube 1710 may be usedto introduce or remove gas to or from an interior of the BSS bottle, tochange a pressure within the BSS bottle, enabling controlled infusion.The tube 1710 may in some embodiments comprise a medical-grade material,such as, for example, 16AWG stainless steel hypodermic tubing.

The example embodiment of FIGS. 17A-17C demonstrates the use of anaseptic container to house the non-sterile BSS bottle and provide asterile barrier so that the BSS bottle can be located within the sterilefield and in close proximity to the surgical site. Placing the BSSbottle closer to the patient and/or closer to the pumping source canallow for better and more precise fluidic management.

Peristaltic Pump

Peristaltic pumps may be utilized in various surgical procedures forpumping of fluids. In some embodiments, a peristaltic pump is configuredor designed to accommodate gas sterilization such as ethylene oxidesterilization. In order to allow the gas to enter and escape from thetubing used in a peristaltic pump, it is desirable to avoid multipleoccluding “pinch-points” that effectively trap a section or portion ofthe tubing such that there is no ingress or egress path for the gas toflow in or out. This for example may occur with a peristaltic pump with3 or more rollers that are pinching the tubing in more than onelocation. Embodiments disclosed herein comprise a peristaltic pump orpump head with a roller or rollers (or components that perform the samepurpose as the roller or rollers) that are configured to enable the pumpto comprise a sterilization position or configuration, wherein a maximumof one pinch-point is created (or zero pinch points in someembodiments), enabling gas sterilization to occur without any “trapped”sections of tubing. The pump may also comprise a pumping or operationalposition or configuration, preferably to be utilized after sterilizationhas occurred, wherein more than one simultaneous pinch-points may becreated while the pump is being used to pump fluids. For example, someembodiments comprise two rollers or a single roller (or components thatperform the same purpose as the roller or rollers) such that a maximumof one part of the tubing is pinched at any given time in thesterilization configuration. Some embodiments may comprise even morethan two rollers, as long as the pump is configurable such that no morethan one part of the tubing is pinched in at least one configuration(for example, the sterilization configuration). The pump design mayinclude keyways and/or other features that ensure proper alignmentduring assembly such that only a single roller is engaged with thetubing in the sterilization configuration. See FIG. 18 for an examplethat comprises two rollers 1806 that are capable of pinching the tubing1808 simultaneously in two locations, but the rollers 1806 are arrangedsuch that, if the rotor 1804 is in a particular position (for example,the position in which the rotor 1804 is shown in FIG. 18), only onepinch point will be created. Accordingly, such a pump could beconfigured to use the position or configuration illustrated in FIG. 18as a “home,” starting, or sterilization position, enabling gassterilization prior to use in surgery.

With further reference to FIG. 18, FIG. 18 is a top view of a 2-rollerperistaltic pump 1800 (or a pump head portion of a pump) showing in thisconfiguration a single pinch point 1810 (at 12 o'clock in this figure).The bottom roller 1806 (at 6 o'clock) does not pinch the tubing 1808 inthis orientation, allowing sterilization gas (for example, ethyleneoxide) to enter and exit both ends of the tubing 1808 during themanufacturing process. When the pump 1800 is activated, the rotor 1804and rollers 1806 will rotate clockwise or counter-clockwise providing aperistaltic pumping action (during which more than one pinch point willbe created). In some embodiments, the pump components may contain keyedareas or other features to ensure proper alignment during assembly suchthat only a single roller is pinching the tubing.

In some embodiments, a peristaltic pump may enable gas sterilization inother ways. For example, a pump may include an expanding iris oraperture type configuration whereby prior to initial use or activationthe rollers are disengaged along a smaller or greater diameter than thetubing itself (and therefore not pinching the tubing), and uponactivating the motor the rollers engage along substantially the sameradius as the tubing to provide a peristaltic pumping action.

FIGS. 19A and 19B illustrate another embodiment of a peristaltic pump orpump head 1900 configured to enable efficient gas sterilization. Similarto the embodiment illustrated in FIG. 18, the peristaltic pumps 1900comprises a sterilization configuration, wherein the tubing 1908comprises no trapped pockets of air, and an operating configuration,wherein multiple pinch-points 1910 may be created. FIG. 19A illustratesthe peristaltic pump 1900 in the sterilization configuration. In thisembodiment, there are zero pinch-points in the sterilizationconfiguration. In other embodiments, however, similar to as shown inFIG. 18, one pinch point may be utilized in the sterilizationconfiguration. FIG. 19B illustrates the peristaltic pump 1900 in theoperating configuration. In this figure, two simultaneous pinch-points1910 are being created. Depending on the position of the rotor 1904,however, all three rollers 1906 may generate pinch-points 1910simultaneously.

The peristaltic pump 1900 comprises a housing 1902, a rotor 1904rotatably coupled to the housing 1902, and a plurality of rollers 1906,in this case three rollers. The peristaltic pump 1900 further comprisesperistaltic tubing 1908 positioned around the rotor 1904 and positionedto be engageable by the rollers 1906 to enable fluid to be pumped withinthe tubing 1908. In the embodiment illustrated in FIGS. 19A and 19B, therotor 1904 further comprises a channel 1912 (e.g., keyway, slot, guide,and/or the like) for each of the rollers 1906. The channels 1912 extendabout the rotor 1904 in a curved fashion, wherein the channel 1912 isfurther from a central axis of the rotor 1904 at one end and closer tothe central axis of the rotor 1904 at another end. Such a design canenable the rollers 1906 to be repositioned within the channel 1912 suchthat, at one end of the channel, as shown in FIG. 19A, no pinch-point iscreated between the roller 1906 and the tubing 1908. However, when theroller 1906 is at the other end of the channel, as illustrated in FIG.19B, the roller 1906 is further away from the central axis of the rotor1904 (and closer to the tubing 1908), creating an interference fit orpinch-point 1910 between the tubing 1908 and the roller 1906.

In some embodiments, the peristaltic pump 1900 illustrated in FIGS. 19Aand 19B can be configured to automatically engage and/or disengage therollers 1906. For example, the orientation of the channels 1912 can besuch that a clockwise rotation of the rotor 1904 automatically resultsin the rollers 1906 moving counterclockwise with respect to the rotor1904, and thus engaging the tubing 1908. Similarly, a counterclockwiserotation of the rotor 1904 can enable the rollers 1906 to automaticallymove within the channels 1912 in a clockwise direction with respect tothe rotor 1904, thus automatically disengaging the tubing 1908 to enablegas sterilization. In some embodiments, the peristaltic pump 1900 maycomprise springs or other mechanisms that bias the rollers 1906 towardone end of the channels 1912. For example, the peristaltic pump 1900 maycomprise a spring that biases the rollers 1906 into the disengagedposition, shown in FIG. 19A, to ensure that gas sterilization can occurwith a pump that has not yet been activated or connected to a powersource. As another example, the peristaltic pump 1900 may comprise aspring that biases the rollers 1906 into the engaged position, shown inFIG. 19B, to ensure that the rollers 1906 remain engaged with the tubing1908 during operation. In some embodiments, instead of springs, or inaddition to springs, a locking mechanism may be utilized that locks therollers 1906 into position at either end of the channels 1912, to ensurethe pump 1900 remains in either of the sterilization or operatingconfigurations. In some embodiments, the face of the rotor 1904 maycomprise a cam disk that comprises the channels 1912. The cam disk canbe rotated with respect to the rest of the rotor to enable the rollers1906 to move inwardly and outwardly.

The peristaltic pump 1900 illustrated in FIGS. 19A and 19B depicts oneexample embodiment of a peristaltic pump that comprises rollersselectively engageable with peristaltic tubing. One of skill in the artwill recognize that various other designs may be utilized to performsuch an action. For example, a peristaltic pump may comprise channels orkeyways that enable a roller to move directly inward and outward withrespect to the tubing 1908 (for example, in a direction perpendicular toa tangent of the tubing at the point where the roller would pinch thetubing). In such an embodiment, the rollers may be configured to moveinwardly and outwardly by, for example, a cam mechanism that selectivelyengages the rollers with the tubing. In another embodiment, rollers maybe mounted to pivoting and/or spring-loaded arms that may be movedinwardly or outwardly to selectively engage the rollers with the tubing.

Anterior Chamber Surgical System

In an embodiment, the surgical systems illustrated herein can beconfigured for anterior chamber surgical procedures, for example lens orcataract removal (commonly known as phacoemulsification orphacomorcellation). The surgical system can include one or more of thefollowing: a handpiece, a console, a surgical tray, a display, a footpedal.

Handpiece

In an embodiment, the system includes a handpiece held by the surgeon,the distal end of which is inserted into the anterior chamber of the eyethrough a small incision. The distal tip of the handpiece can beinserted into the eye and can be, for example, a hypodermic needle,tube, cannula, or trocar of size 17, 18, 19, 20, 21, 22, 23, 24, 25, 26,or 27 gauge, or in some cases larger or smaller gauge and made of any ofa variety of materials, including stainless steel, titanium, plastic,polyimide, or the like.

In an embodiment, one function of the distal tip that is inserted intothe eye is to break up, emulsify, and/or morcellate the cataract orlens, through ultrasonic vibrations, mechanical cutting and/oragitation, ablation, laser, and/or other techniques. In an embodiment,the system can include a hollow channel inside the probe tip for theaspiration or infusion of fluids and tissues. In an embodiment, thesystem can include a separate hollow channel for infusion and aspirationthat is located adjacent to or positioned near the probe tip that breaksup the cataract or lens.

In an embodiment, the system can include mechanisms for vibrating,oscillating, reciprocating, rotating, cantilevering, and/or otherwisetranslating the position of the needle in one or more axes, for example,at a frequency in the kilohertz or higher range. This motion can begenerated through the use of piezoelectric materials (such asLead-Zirconate-Titanate, aka PZT or a commonly available piezo benderelement) that vibrate when driven by a time varying voltage signal; itcan be generated through the use of electromagnetics, for example in avoice-coil actuator, solenoid, or motor configuration; it can begenerated through pneumatics or hydraulics: it can be generated throughtransmission drive systems, such as a rotating or reciprocating cable,drive belt, geared transmission, or push-pull mechanism.

In an embodiment, the system can comprise mechanisms for mechanicallycutting or agitating a tissue sample (e.g. lens, cataract). This caninclude a guillotine or rotating (360 degrees or a portion thereof, forexample 180 degrees reciprocating) cutting mechanism such as those usedfor vitreous removal or tissue debridement. Other mechanisms can includea rotating or otherwise moving/translating a whisk or whisks at thedistal end of the probe that break up the tissue of interest through themechanical movement of the whisk.

In an embodiment, the system can be configured to utilize amonochromatic or narrow-band light source (for example, laser or LED orthe like) or a broadband light source to prepare the cataract, lens, orother tissue of interest for removal via photochemical, photomechanical,and/or photothermal means. The light source may be located in thehandpiece itself or located elsewhere (for example, in the console ortray) and optically routed to the handpiece via a single mode ormulti-mode fiber or fiber bundle (as previously described).

In an embodiment, the system can be configured to utilize heat or RFenergy to cauterize or ablate tissue of interest (including but notlimited to cataracts and lens material).

In an embodiment, a second function of the distal tip of the handpiecethat is inserted into the eye can be to aspirate tissue and fluid,including the lens and cataract fragments generated by the action of theprobe tip. The probe tip can be connected to a pump system that createsvacuum pressure at the needle tip to aspirate fragments smaller than theinner diameter of the needle tip and to hold fragments larger than theinner diameter until they are emulsified, morcellated, or broken up bythe action of the needle tip to a size small enough for aspiration. Theaspiration can be provided by a pump or other means as describedearlier. In an embodiment, the locate the aspiration mechanism (pump orotherwise) can be in a console or tray separate from the handpiece andtethered to the handpiece via tubing suitable for the aspiration offluids, for example, flexible vinyl or PVC tubing. The close proximityof the tray reduces the length requirements of the tubing set, improvingthe performance and responsiveness of the aspiration. In an embodiment,the locate the aspiration mechanism (pump or otherwise) can be insidethe handpiece or adjacent to the handpiece. This can be advantageousbecause such a design reduces the path length of the aspirated fluid,thereby reducing the requirements of the aspiration mechanism andeliminating long tubing sets that slow the response time (for example,when the surgeon changes the rate of aspiration) and can entangle thesurgeon and assistants in the operating room.

Embodiments of the invention incorporate a pressure sensor in the distaltip of the handpiece as previously described, wherein the pressuresensor readings are used to control the rate of infusion (and/oraspiration) during a procedure. The control can be in the form of afeedback control loop (e.g. proportional-integral-derivative aka PID, asubset thereof, or similar). A simpler embodiment displays the pressureinformation to the surgeon, who can then manually control the rate ofinfusion. The system can alert the surgeon when the pressure fallsoutside of a preset range of pressures.

In an embodiment, the system can be configured to include some or all ofthe required functionality for anterior segment procedures, and inparticular lens and cataract removal, in a single handpiece. Thehandpiece can include a mechanism for emulsification or morcellation(using one or more of the mechanisms previously described above). Thehandpiece can also comprise a mechanism for aspiration (such as a pumpor one or more of the mechanisms previously described). The handpiecemay include a mechanism for providing infusion into the eye (includingany of the means previously described), or the infusion may be providedby a separate infusion cannula and infusion fluid source andcontrolled/driven by the handpiece or a separate nearby tray or console.

In the self-contained embodiments, the handpiece can include a reservoirthat contains the infusion solution(s) (including BSS, viscoelastics,silicone oil, or the like) used during the procedure. The handpiece canalso include a reservoir for the aspirated waste. The infusion andaspiration reservoirs can be contained within or fully integrated intothe handpiece or they may be located directly adjacent to it (forexample, a bag or bottle hanging from the handpiece or secured to thesurgeon's hand, wrist, or arm). The reservoirs can also be located in,mounted on, or hanging from a nearby tray, surgeon arm support orpatient headrest, or from the microscope.

In an embodiment, the system can be configured to use of a filter (forexample, a porous membrane filter) in-line with the aspiration andinfusions systems so that the aspirated fluid can be filtered andre-infused, significantly reducing the amount of required infusionsolution and decreasing the size and weight requirements of a handheldsystem. The filter (and aspiration pump) can be located in thehandpiece, or in some embodiments one or both may be located in aseparate nearby tray or console with a short tubing set connecting thehandpiece to the filter and/or pump. The filtered system can also beused for posterior segment and vitreo-retinal procedures.

In an embodiment, the self-contained handpiece can comprise theintegrated pressure sensor previously described above, either in thedistal tip of the needle or along the fluid path, utilized in a feedbackcontrol loop to control the rate of infusion (and/or aspiration).

In an embodiment, the system can be configured to be used with valvedcannula(s) and/or valved trocar(s) to reduce leakage of infused fluidfrom the anterior chamber. These devices are commonly used invitreoretinal surgery and orthopedic surgery but not typically inanterior segment procedures. However, incorporating them into theanterior procedure will reduce the required volume of infusion fluids,resulting in a smaller, lighter, and more compact system.

Conditional language, such as, among others, “can,” “could.” “might.” or“may,” unless specifically stated otherwise, or otherwise understoodwithin the context as used, is generally intended to convey that certainembodiments include, while other embodiments do not include, certainfeatures, elements and/or steps. Thus, such conditional language is notgenerally intended to imply that features, elements and/or steps are inany way required for one or more embodiments or that one or moreembodiments necessarily include logic for deciding, with or without userinput or prompting, whether these features, elements and/or steps areincluded or are to be performed in any particular embodiment. Theheadings used herein are for the convenience of the reader only and arenot meant to limit the scope of the inventions or claims.

Although this invention has been disclosed in the context of certainpreferred embodiments and examples, it will be understood by thoseskilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. Additionally, the skilled artisan will recognize that any ofthe above-described methods can be carried out using any appropriateapparatus. Further, the disclosure herein of any particular feature,aspect, method, property, characteristic, quality, attribute, element,or the like in connection with an embodiment can be used in all otherembodiments set forth herein. For all of the embodiments describedherein the steps of the methods need not be performed sequentially.Thus, it is intended that the scope of the present invention hereindisclosed should not be limited by the particular disclosed embodimentsdescribed above.

What is claimed is:
 1. A surgical apparatus for use by a surgeon duringa surgical procedure, the surgical apparatus comprising: one or moresealed sterilized surgical packs configured to be unsealed before asurgical procedure and disposed of after a single or a limited number ofsurgical procedures, the one or more scaled sterilized surgical packscomprising: a sterile surgical instrument; and a sterile surgical traycomprising a top surface configured to be part of a sterile field of thesurgical procedure, the sterile surgical tray further comprising wallsthat define a recess sized and configured to receive a reusablenon-sterile module, the recess configured to encapsulate the reusablenon-sterile module to isolate the reusable non-sterile module from thesterile field of the surgical procedure, wherein the walls of thesterile surgical tray comprises one or more interfaces positioned andconfigured to enable one or more functions of the reusable non-sterilemodule to be utilized in the sterile field of the surgical procedureoutside of the recess, the one or more interfaces comprising at least anelectronic communication interface configured to enable an electroniccontroller of the reusable non-sterile module to electronicallycommunicate with the sterile surgical tray or the sterile surgicalinstrument.
 2. The surgical apparatus of claim 1, wherein the recess iscentrally located in the sterile surgical tray.
 3. The surgicalapparatus of claim 1, wherein the sterile surgical tray comprises atleast two pieces selectively coupleable together to form the recess thatencapsulates the reusable non-sterile module.
 4. The surgical apparatusof claim 1, wherein the sterile surgical tray comprises a hinged openingfor access to the recess.
 5. The surgical apparatus of claim 1, whereinthe one or more interfaces further comprises at least one of thefollowing: a mechanical coupling for transmission of rotational motionfrom a motor of the reusable non-sterile module to a fluid pumpconnected to the sterile surgical tray, and a light transmissioncoupling for transmission of light from a light source of the reusablenon-sterile module to the sterile surgical instrument.
 6. The surgicalapparatus of claim 1, wherein the one or more interfaces furthercomprises an electrically conductive coupling for transmission ofelectrical power from the non-sterile module to the sterile surgicaltray.
 7. The surgical apparatus of claim 1, wherein the one or morefunctions of the reusable non-sterile module comprise at least one ofthe following: providing mechanical power, providing electrical power,providing electronic processing or control, providing a laser source,providing a light source, and displaying information.
 8. A surgicalapparatus for use by a surgeon during a surgical procedure, the surgicalapparatus comprising: one or more sealed sterilized surgical packsconfigured to be unsealed before a surgical procedure and disposed ofafter a single or a limited number of surgical procedures, the one ormore sealed sterilized surgical packs comprising: a sterile surgicalinstrument; and a sterile surgical tray comprising a top surfaceconfigured to be part of a sterile field of the surgical procedure, anda bottom surface sized and configured to couple to and be supported byan upper surface of a reusable support structure, the reusable supportstructure comprising at least one of: a motor, a light source, a userinterface display, a power source, and a computer processor, wherein thesterile surgical tray comprises at least one of: a mechanical couplingfor transmission of rotational motion from the motor of the supportstructure to a fluid pump connected to the sterile surgical tray, alight transmission coupling for transmission of light from the lightsource of the support structure to the sterile surgical instrument, atransparent material positioned to enable the user interface display ofthe support structure to be visible therethrough in the sterile field ofthe surgical procedure, an electrical coupling for transmission ofelectrical power from the power source of the support structure to thesterile surgical tray, and an electronic communication coupling fortransmission of electrical communications from the computer processor tothe sterile surgical tray.
 9. The surgical apparatus of claim 8, whereinthe one or more sealed sterilized surgical packs further comprises asterile drape sized to be positioned between the bottom surface of thesterile surgical tray and the upper surface of the reusable supportstructure.
 10. The surgical apparatus of claim 9, wherein the steriledrape comprises a conductive interface configured to enable electricalcurrent to pass from the reusable support structure to the sterilesurgical tray.
 11. The surgical apparatus of claim 8, wherein thereusable support structure is non-sterile.
 12. The surgical apparatus ofclaim 8, wherein the sterile surgical tray comprises a collapsedshipping configuration and an expanded surgical use configuration. 13.The surgical apparatus of claim 12, wherein at least a portion of thesterile surgical tray is configured to, in the collapsed shippingconfiguration, protect the sterile surgical tool from damage.
 14. Thesurgical apparatus of claim 8, wherein the reusable support structurecomprises the motor, and the one or more sealed sterilized surgicalpacks further comprises a sterile pump module separate from the sterilesurgical tray and configured to separately couple to and be supported bythe reusable support structure, wherein the sterile pump modulecomprises a rotational coupling for transmission of rotational motionfrom the motor to a fluid pump of the pump module.
 15. A surgicalapparatus for use by a surgeon during a surgical procedure, the surgicalapparatus comprising: one or more sealed sterilized surgical packsconfigured to be unsealed before a surgical procedure and disposed ofafter a single or a limited number of surgical procedures, the one ormore sealed sterilized surgical packs comprising one or more of asterile infusion module and a sterile aspiration module, the sterileinfusion and aspiration modules each comprising: a housing comprisingwalls sized and configured to be removably received in a recess of areusable support structure, and at least one outer surface configured tobe part of the sterile field of the surgical procedure: a pump forpumping fluids into or out of a surgical site; and a motor coupled tothe pump for rotating a rotor of the pump, wherein the housing furthercomprises an electrical interface configured to receive electrical powerfrom the reusable support structure for powering the motor, wherein thesterile infusion module is configured to pump fluids into the surgicalsite, and the sterile aspiration module is configured to pump fluids outof the surgical site.
 16. The surgical apparatus of claim 15, whereinthe one or more scaled sterilized surgical packs comprises at least oneof each of the sterile infusion module and the sterile aspirationmodule.
 17. The surgical apparatus of claim 15, wherein the pumpcomprises a sterilization configuration wherein at most one pinch-pointis created in peristaltic tubing of the pump.
 18. The surgical apparatusof claim 15, wherein the one or more sealed sterilized surgical packsfurther comprises: a sterile surgical instrument; and a sterile surgicalinstrument holder comprising a top surface configured to be part of thesterile field of the surgical procedure, the top surface comprising areceiving portion for positioning therein or thereon of the sterilesurgical instrument, the sterile surgical instrument holder furthercomprising a bottom surface sized and configured to be received in adifferent recess of the reusable support structure.
 19. The surgicalapparatus of claim 18, wherein the sterile surgical instrument isconfigured to couple with one or more of: a light source of the reusablesupport structure, an electronic controller of the reusable supportstructure, a mechanical driver of the reusable support structure, apneumatic driver of the reusable support structure, and a fluidic driverof the reusable support structure.
 20. The surgical apparatus of claim15, wherein the reusable support structure is non-sterile, and the oneor more sealed sterilized surgical packs further comprises a surgicaldrape configured be positioned between the non-sterile reusable supportstructure and at least one of the modules.